Download PDF

Clinical Trial Results:
A Phase 3 Double-blind,Randomized, Placebo-Controlled,Parallel-Group Study to Assess The Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Summary
EudraCT number	2013-002642-37
Trial protocol	CZ DE IT PL
Global end of trial date	05 Apr 2016

Results information
Results version number	v1(current)
This version publication date	22 Apr 2017
First version publication date	22 Apr 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

B1481019

ISRCTN number

US NCT number

NCT01968954

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

08 Feb 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

05 Apr 2016

Was the trial ended prematurely?

Main objective of the trial

To demonstrate a superior low-density lipoprotein-cholesterol (LDL-C) lowering effect of PF-04950615 150 milligram (mg) administered by the subcutaneous (SC) route every 2 weeks compared to placebo, in subjects with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for cardiovascular events receiving a maximally tolerated dose of statin therapy and whose LDL-C was greater than or equal to (>=) 70 milligram per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Oct 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 18

Country: Number of subjects enrolled

Canada: 39

Country: Number of subjects enrolled

Czech Republic: 7

Country: Number of subjects enrolled

Germany: 30

Country: Number of subjects enrolled

Hong Kong: 6

Country: Number of subjects enrolled

Italy: 27

Country: Number of subjects enrolled

Korea, Republic of: 68

Country: Number of subjects enrolled

Poland: 95

Country: Number of subjects enrolled

United States: 421

Worldwide total number of subjects

711

EEA total number of subjects

159

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

413

From 65 to 84 years

297

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

This study was conducted from 23 October 2013 to 05 April 2016 in Australia, Canada, Czech Republic, Germany, Hong Kong, Italy, Korea, Republic of, Poland and United States.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks.

PF-04950615 150 mg

Arm description

Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Arm type

Experimental

Investigational medicinal product name

PF-04950615

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks.

Number of subjects in period 1	Placebo	PF-04950615 150 mg
Started	354	357
Treated	353	356
Completed	314	314
Not completed	40	43
Consent withdrawn by subject	20	23
Did not meet inclusion criteria	-	2
Unspecified	8	10
Adverse Events	6	3
Lost to follow-up	6	4
Protocol deviation	-	1

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Reporting group title

PF-04950615 150 mg

Reporting group description

Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Reporting group values	Placebo	PF-04950615 150 mg	Total
Number of subjects	354	357	711
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	201	212	413
From 65-84 years	153	144	297
85 years and over	0	1	1
Age Continuous
Units: years
arithmetic mean (standard deviation)	61.5 ( 9.7 )	61.1 ( 10.2 )	-
Gender, Male/Female
Units: Subjects
Female	130	136	266
Male	224	221	445

End points

Top of page

Reporting group title

Placebo

Reporting group description

Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Reporting group title

PF-04950615 150 mg

Reporting group description

Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Top of page

End point title

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

End point description

Full analysis set (FAS) included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	329	336
Units: percent change
arithmetic mean (standard deviation)	1 ( 20.89 )	-55.6 ( 29.17 )

Week 12

Statistical analysis description

LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

665

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed Model Repeated Measures (MMRM)

Parameter type

Least Square (LS) Mean Difference

Point estimate

-57

Confidence interval

level

95%

sides

2-sided

lower limit

-61

upper limit

-53.1

Variability estimate

Standard error of the mean

Dispersion value

Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 340)	1 ( 14.85 )	-35.1 ( 19.23 )
Week 24 (n =331, 337)	3.2 ( 19.35 )	-31.7 ( 20.47 )
Week 52 (n =313, 315)	1.8 ( 18.5 )	-27.3 ( 23.57 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

-36.2

Confidence interval

level

95%

sides

2-sided

lower limit

-38.8

upper limit

-33.6

Variability estimate

Standard error of the mean

Dispersion value

1.33

Week 24

Statistical analysis description

LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-34.7

Confidence interval

level

95%

sides

2-sided

lower limit

-37.7

upper limit

-31.7

Variability estimate

Standard error of the mean

Dispersion value

1.52

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-29

Confidence interval

level

95%

sides

2-sided

lower limit

-32.3

upper limit

-25.7

Variability estimate

Standard error of the mean

Dispersion value

1.69

Secondary: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 339)	1.3 ( 19.53 )	-50 ( 26.28 )
Week 24 (n =329, 336)	4.7 ( 27.81 )	-46.2 ( 28.52 )
Week 52 (n =312, 314)	2.3 ( 25.22 )	-38.9 ( 33.32 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

-51.6

Confidence interval

level

95%

sides

2-sided

lower limit

-55.2

upper limit

-48.1

Variability estimate

Standard error of the mean

Dispersion value

1.8

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-41.2

Confidence interval

level

95%

sides

2-sided

lower limit

-45.8

upper limit

-36.5

Variability estimate

Standard error of the mean

Dispersion value

2.38

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-50.6

Confidence interval

level

95%

sides

2-sided

lower limit

-54.9

upper limit

-46.4

Variability estimate

Standard error of the mean

Dispersion value

2.15

Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 339)	0.3 ( 19.1 )	-51.1 ( 27.62 )
Week 24 (n =331, 335)	3.5 ( 22.39 )	-47.3 ( 30.43 )
Week 52 (n =313, 313)	1.9 ( 22.25 )	-39.1 ( 33.39 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

-51.5

Confidence interval

level

95%

sides

2-sided

lower limit

-55.1

upper limit

-47.9

Variability estimate

Standard error of the mean

Dispersion value

1.84

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-50.6

Confidence interval

level

95%

sides

2-sided

lower limit

-54.6

upper limit

-46.6

Variability estimate

Standard error of the mean

Dispersion value

2.05

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-40.8

Confidence interval

level

95%

sides

2-sided

lower limit

-45.2

upper limit

-36.3

Variability estimate

Standard error of the mean

Dispersion value

2.26

Secondary: Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 339)	4.7 ( 84.86 )	1.9 ( 508.44 )
Week 24 (n =331, 336)	1.9 ( 51.82 )	4.4 ( 465.24 )
Week 52 (n =311, 311)	1.1 ( 42.47 )	17.3 ( 562.63 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.86

Method

MMRM

Parameter type

LS mean difference

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-35.4

upper limit

29.5

Variability estimate

Standard error of the mean

Dispersion value

16.55

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-47.2

upper limit

51.4

Variability estimate

Standard error of the mean

Dispersion value

25.11

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

12.9

Confidence interval

level

95%

sides

2-sided

lower limit

-44.5

upper limit

70.4

Variability estimate

Standard error of the mean

Dispersion value

29.25

Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n= 330, 339)	1.9 ( 17.24 )	6.6 ( 14.24 )
Week 24 (n =329, 336)	1 ( 15.78 )	7.8 ( 15.91 )
Week 52 (n =312, 314)	2 ( 15.73 )	5.3 ( 16.59 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

4.7

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.19

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

6.8

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

9.1

Variability estimate

Standard error of the mean

Dispersion value

1.18

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

3.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

5.8

Variability estimate

Standard error of the mean

Dispersion value

1.25

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia

Top of page

End point title

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia

End point description

Subjects with primary hyperlipidemia was defined as subjects with triglycerides (TG) level less than (<) 200 mg/dL (2.26 mmol/L) at pre-randomization. FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	262	266
Units: percent change
arithmetic mean (standard deviation)	1.5 ( 20.89 )	-56.8 ( 27.78 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

528

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

-59.1

Confidence interval

level

95%

sides

2-sided

lower limit

-63.4

upper limit

-54.8

Variability estimate

Standard error of the mean

Dispersion value

2.19

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia

Top of page

End point title

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia

End point description

Subjects with mixed dyslipidemia were defined as TG level >=200 mg/dL (2.26 mmol/L) at pre-randomization. FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	67	70
Units: percent change
arithmetic mean (standard deviation)	-1 ( 20.95 )	-50.9 ( 33.78 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference

Point estimate

-48.7

Confidence interval

level

95%

sides

2-sided

lower limit

-58

upper limit

-39.3

Variability estimate

Standard error of the mean

Dispersion value

4.72

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 24 (n =331, 336)	6.3 ( 32.52 )	-50 ( 31.36 )
Week 52 (n =311, 313)	5.2 ( 29.69 )	-40.9 ( 38.02 )

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-56

Confidence interval

level

95%

sides

2-sided

lower limit

-60.8

upper limit

-51.2

Variability estimate

Standard error of the mean

Dispersion value

2.45

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-46.4

Confidence interval

level

95%

sides

2-sided

lower limit

-51.8

upper limit

-41

Variability estimate

Standard error of the mean

Dispersion value

2.77

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

Top of page

End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

End point description

Percent change from baseline in fasting LDL-C among subjects with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this endpoint. FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
TG <200 mg/dL: Week 24 (n =261, 265)	7.2 ( 34.38 )	-50.8 ( 30.9 )
TG <200 mg/dL: Week 52(n =243, 248)	6.2 ( 29.95 )	-41.1 ( 38.35 )
TG >=200 mg/dL: Week 24(n =70, 71)	3 ( 24.3 )	-46.9 ( 33.05 )
TG >=200 mg/dL: Week 52(n =68, 65)	2 ( 28.74 )	-40.1 ( 37.01 )

TG <200 mg/dL: Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-57.6

Confidence interval

level

95%

sides

2-sided

lower limit

-63.1

upper limit

-52

Variability estimate

Standard error of the mean

Dispersion value

2.82

TG <200 mg/dL: Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-47.7

Confidence interval

level

95%

sides

2-sided

lower limit

-53.9

upper limit

-41.5

Variability estimate

Standard error of the mean

Dispersion value

3.16

TG >=200 mg/dL: Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-49.3

Confidence interval

level

95%

sides

2-sided

lower limit

-58.9

upper limit

-39.8

Variability estimate

Standard error of the mean

Dispersion value

4.83

TG >=200 mg/dL: Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-41.2

Confidence interval

level

95%

sides

2-sided

lower limit

-52.2

upper limit

-30.1

Variability estimate

Standard error of the mean

Dispersion value

5.6

Secondary: Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 340)	5.9 ( 34.9 )	-9.4 ( 42 )
Week 24 (n =331, 336)	7 ( 37.79 )	-13.8 ( 33.24 )
Week 52 (n =313, 315)	0.6 ( 38.33 )	-9.3 ( 48.47 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-14.2

Confidence interval

level

95%

sides

2-sided

lower limit

-19.9

upper limit

-8.5

Variability estimate

Standard error of the mean

Dispersion value

2.88

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-19.9

Confidence interval

level

95%

sides

2-sided

lower limit

-25.1

upper limit

-14.7

Variability estimate

Standard error of the mean

Dispersion value

2.65

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-9.2

Confidence interval

level

95%

sides

2-sided

lower limit

-15.7

upper limit

-2.8

Variability estimate

Standard error of the mean

Dispersion value

3.31

Secondary: Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 339)	-0.3 ( 14.05 )	3.7 ( 12.56 )
Week 24 (n =331, 336)	-0.8 ( 12.77 )	4.3 ( 12.25 )
Week 52 (n =313, 313)	0.4 ( 13.13 )	3.3 ( 13 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

3.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

5.7

Variability estimate

Standard error of the mean

Dispersion value

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

3.1

upper limit

6.7

Variability estimate

Standard error of the mean

Dispersion value

0.91

Week 54

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

2.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

4.6

Variability estimate

Standard error of the mean

Dispersion value

0.98

Secondary: Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =327, 339)	-1.8 ( 12.92 )	-1.9 ( 12.1 )
Week 24 (n =331, 335)	-3.7 ( 14.4 )	-1.9 ( 13.25 )
Week 52 (n =310, 310)	-3 ( 14.76 )	-1.6 ( 12.91 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

1.7

Variability estimate

Standard error of the mean

Dispersion value

0.93

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

3.9

Variability estimate

Standard error of the mean

Dispersion value

1.02

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

3.1

Variability estimate

Standard error of the mean

Dispersion value

1.03

Secondary: Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =330, 340)	5.9 ( 34.9 )	-9.4 ( 42 )
Week 24 (n =331, 336)	7 ( 37.79 )	-13.8 ( 33.24 )
Week 52 (n =313, 315)	0.6 ( 38.33 )	-9.3 ( 48.47 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS-Mean Difference

Point estimate

-14.2

Confidence interval

level

95%

sides

2-sided

lower limit

-19.9

upper limit

-8.5

Variability estimate

Standard error of the mean

Dispersion value

2.88

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-19.9

Confidence interval

level

95%

sides

2-sided

lower limit

-25.1

upper limit

-14.7

Variability estimate

Standard error of the mean

Dispersion value

2.65

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-9.2

Confidence interval

level

95%

sides

2-sided

lower limit

-15.7

upper limit

-2.8

Variability estimate

Standard error of the mean

Dispersion value

3.31

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off

Top of page

End point title

Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off

End point description

Change from baseline in fasting LDL-C among subjects with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this endpoint. FAS included all subjects who were randomized. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable in this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	353	357
Units: mg/dL
arithmetic mean (standard deviation)
TG <200 mg/dL: Baseline (n =282, 282)	111.2 ( 31.28 )	112.8 ( 36.42 )
TG <200 mg/dL: Change at Week12 (n =262, 266)	0.4 ( 22.6 )	-63.4 ( 37.38 )
TG >=200 mg/dL: Baseline (n =71, 75)	126.5 ( 42.07 )	125.7 ( 42.1 )
TG >=200 mg/dL: Change at Week 12 (n =67, 70)	-2.6 ( 26.98 )	-63.1 ( 44.91 )

TG <200 mg/dL: Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

710

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-64.2

Confidence interval

level

95%

sides

2-sided

lower limit

-69.1

upper limit

-59.2

Variability estimate

Standard error of the mean

Dispersion value

2.51

TG >=200 mg/dL: Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

710

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-59.6

Confidence interval

level

95%

sides

2-sided

lower limit

-71.4

upper limit

-47.7

Variability estimate

Standard error of the mean

Dispersion value

5.99

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =353, 357)	114.3 ( 34.22 )	115.5 ( 37.99 )
Change at Week 12 (n =329, 336)	-0.2 ( 23.55 )	-63.3 ( 39 )
Change at Week 24 (n =331, 336)	5.5 ( 33.14 )	-56 ( 39.34 )
Change at Week 52 (n =311, 313)	3.9 ( 32.17 )	-45.9 ( 46.43 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-63.4

Confidence interval

level

95%

sides

2-sided

lower limit

-68

upper limit

-58.8

Variability estimate

Standard error of the mean

Dispersion value

2.35

Secondary: Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	186 ( 40.04 )	189 ( 44.68 )
Change at Week 12 (n =330, 340)	0.6 ( 27.64 )	-66.8 ( 42.38 )
Change at Week 24 (n =331, 337)	5.1 ( 35.83 )	-60.1 ( 43.33 )
Change at Week 52 (n =313, 315)	1.8 ( 35.18 )	-51.9 ( 49.68 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-67.1

Confidence interval

level

95%

sides

2-sided

lower limit

-72.2

upper limit

-62.1

Variability estimate

Standard error of the mean

Dispersion value

2.59

Secondary: Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	137.2 ( 37.38 )	140.1 ( 43.48 )
Change at Week 12 (n =330, 339)	0.3 ( 26.53 )	-69.8 ( 43.53 )
Change at Week 24 (n =329, 336)	5.2 ( 35.91 )	-63.6 ( 44.37 )
Change at Week 52 (n =312, 314)	1.3 ( 33.93 )	-53.9 ( 51.1 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-69.7

Confidence interval

level

95%

sides

2-sided

lower limit

-74.7

upper limit

-64.6

Variability estimate

Standard error of the mean

Dispersion value

2.57

Secondary: Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	94 ( 21.51 )	95.1 ( 25.57 )
Change at Week 12 (n =330, 339)	-0.5 ( 17.32 )	-47.9 ( 28.4 )
Change at Week 24 (n =331, 335)	2.5 ( 19.87 )	-43.9 ( 29.95 )
Change at Week 52 (n =313, 313)	0.9 ( 20.59 )	-36.4 ( 32.23 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-47.3

Confidence interval

level

95%

sides

2-sided

lower limit

-50.7

upper limit

-43.8

Variability estimate

Standard error of the mean

Dispersion value

1.74

Secondary: Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =353, 356)	44 ( 45.93 )	45.1 ( 52.3 )
Change at Week 12 (n =330, 339)	-0.6 ( 10.42 )	-11.4 ( 22.19 )
Change at Week 24 (n =331, 336)	-1.2 ( 12.62 )	-10.6 ( 20.16 )
Change at Week 52 (n =311, 311)	-1 ( 10.71 )	-8.6 ( 23.78 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-10.6

Confidence interval

level

95%

sides

2-sided

lower limit

-12.9

upper limit

-8.3

Variability estimate

Standard error of the mean

Dispersion value

1.17

Secondary: Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	48.7 ( 12.52 )	49 ( 13.23 )
Change at Week 12 (n =330, 339)	0.4 ( 7.5 )	2.9 ( 6.92 )
Change at Week 24 (n =329, 336)	0 ( 7.9 )	3.3 ( 7.41 )
Change at Week 52 (n =312, 314)	0.6 ( 7.59 )	2.1 ( 8.32 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

3.5

Variability estimate

Standard error of the mean

Dispersion value

0.55

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: ratio
arithmetic mean (standard deviation)
Baseline (n =354, 357)	4 ( 1.1 )	4.1 ( 1.26 )
Change at Week 12 (n =330, 339)	0 ( 0.71 )	-1.6 ( 1.17 )
Change at Week 24 (n =329, 336)	0.1 ( 0.93 )	-1.5 ( 1.21 )
Change at Week 52 (n =312, 314)	0 ( 0.85 )	-1.2 ( 1.35 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.06

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.08

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.08

Secondary: Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: ratio
arithmetic mean (standard deviation)
Baseline (n =354, 357)	0.7 ( 0.18 )	0.7 ( 0.21 )
Change at Week 12 (n =330, 339)	0 ( 0.12 )	-0.3 ( 0.21 )
Change at Week 24 (n =331, 335)	0 ( 0.16 )	-0.3 ( 0.24 )
Change at Week 52 (n =313, 313)	0 ( 0.14 )	-0.3 ( 0.25 )

Week 12

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.01

Week 24

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.01

Week 52

Statistical analysis description

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.02

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52

Top of page

End point title

Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Week 12, 24 and 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percentage of subjects
number (not applicable)
Week 12 (n =330, 336)	41.5	87.5
Week 24 (n =332, 336)	37.3	82.1
Week 52 (n =312, 313)	36.9	77.3

Week 12

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

13.86

upper limit

41.64

Week 24

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

14.8

Confidence interval

level

95%

sides

2-sided

lower limit

9.32

upper limit

23.56

Week 52

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

9.8

Confidence interval

level

95%

sides

2-sided

lower limit

6.36

upper limit

15.24

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52

Top of page

End point title

Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.

End point type

Secondary

End point timeframe

Week 12, 24 and 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: percentage of subjects
number (not applicable)
Week 12 (n =330, 336)	5.5	76.8
Week 24 (n =332, 336)	3.3	69.6
Week 52 (n =312, 313)	6.4	61.7

Week 12

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

95.2

Confidence interval

level

95%

sides

2-sided

lower limit

52.09

upper limit

173.91

Week 24

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

112.2

Confidence interval

level

95%

sides

2-sided

lower limit

55.81

upper limit

225.52

Week 52

Comparison groups

Placebo v PF-04950615 150 mg

Number of subjects included in analysis

711

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Odds ratio (OR)

Point estimate

29.1

Confidence interval

level

95%

sides

2-sided

lower limit

17.13

upper limit

49.49

Secondary: Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Top of page

End point title

Plasma PF-04950615 Concentrations at Week 12, 24 and 52 ^[1]

End point description

Analysis set included subjects who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those subjects who were evaluable at specified time points.

End point type

Secondary

End point timeframe

Week 12, 24, 52

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis was performed for this endpoint.

End point values	PF-04950615 150 mg
Number of subjects analysed	356
Units: microgram per milliliter
arithmetic mean (standard deviation)
Week 12 (n =332)	5.53 ( 5.666 )
Week 24 (n =327)	5.36 ( 6.029 )
Week 52 (n =306)	4.07 ( 4.947 )

No statistical analyses for this end point

Secondary: Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

Top of page

End point title

Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

End point description

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Subjects with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this endpoint. Safety analysis set included all subjects who received at least 1 dose of study treatment.

End point type

Secondary

End point timeframe

Baseline up to the end of study (up to 58 weeks)

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	353	356
Units: subjects
Type 1 or 3 hypersensitivity reactions	2	1
Injection site reactions	5	42

No statistical analyses for this end point

Secondary: Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Top of page

End point title

Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) ^[2]

End point description

Percentage of subjects with at least 1 positive ADA titer and 1 positive nAb titer were reported. Subjects with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive. Safety analysis set includes all subjects who received at least 1 dose of study treatment. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.

End point type

Secondary

End point timeframe

Baseline up to the end of study (up to 58 weeks)

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis was performed for this endpoint.

End point values	PF-04950615 150 mg
Number of subjects analysed	352
Units: percentage of subjects
ADA	44
nAb	27

No statistical analyses for this end point

Other pre-specified: Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Other pre-specified

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	149.5 ( 66.83 )	156.2 ( 78.75 )
Change at Week 12 (n =330, 340)	3.8 ( 57.04 )	-23 ( 71.52 )
Change at Week 24 (n =331, 336)	5 ( 64.34 )	-28.9 ( 68.41 )
Change at Week 52 (n =313, 315)	-7.7 ( 64.14 )	-24.3 ( 82.21 )

No statistical analyses for this end point

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Other pre-specified

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =354, 357)	147.5 ( 24.25 )	147.2 ( 24.96 )
Change at Week 12 (n =330, 339)	-1.2 ( 19.46 )	4.6 ( 18.32 )
Change at Week 24 (n =331, 336)	-2.3 ( 19.33 )	5.6 ( 17.53 )
Change at Week 52 (n =313, 313)	-0.2 ( 19.56 )	3.8 ( 18.86 )

No statistical analyses for this end point

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Top of page

End point title

Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.

End point type

Other pre-specified

End point timeframe

Baseline, Week 12, 24, 52

End point values	Placebo	PF-04950615 150 mg
Number of subjects analysed	354	357
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =353, 356)	38.1 ( 6.46 )	38.2 ( 6.58 )
Change at Week 12 (n =327, 339)	-0.9 ( 4.95 )	-0.9 ( 4.63 )
Change at Week 24 (n =331, 335)	-1.7 ( 5.65 )	-1 ( 5.07 )
Change at Week 52 (n =310, 310)	-1.5 ( 5.54 )	-0.9 ( 5.15 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline up to the end of study (up to 58 weeks)

Adverse event reporting additional description

The same events may occur as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

Placebo

Reporting group description

Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Reporting group title

PF-04950615 150 mg

Reporting group description

Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

Serious adverse events	Placebo	PF-04950615 150 mg
Total subjects affected by serious adverse events
subjects affected / exposed	40 / 353 (11.33%)	45 / 356 (12.64%)
number of deaths (all causes)	3	2
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
subjects affected / exposed	0 / 353 (0.00%)	2 / 356 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 353 (0.57%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Malignant melanoma of sites other than skin
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Prostate cancer
Additional description: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.
subjects affected / exposed ^[1]	1 / 224 (0.45%)	0 / 221 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm rupture
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	3 / 353 (0.85%)	2 / 356 (0.56%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Completed suicide
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Suicidal behaviour
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Craniocerebral injury
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	0 / 353 (0.00%)	2 / 356 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular graft complication
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	2 / 353 (0.57%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	1 / 353 (0.28%)	3 / 356 (0.84%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	2 / 353 (0.57%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	2 / 353 (0.57%)	2 / 356 (0.56%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	3 / 353 (0.85%)	5 / 356 (1.40%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Myocardial ischaemia
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Intracranial aneurysm
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lethargy
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve root compression
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal aneurysm
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Faecaloma
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric artery stenosis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	2 / 353 (0.57%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bursitis
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 353 (0.28%)	2 / 356 (0.56%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis staphylococcal
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 353 (0.28%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 353 (0.28%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	2 / 353 (0.57%)	0 / 356 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 353 (0.00%)	1 / 356 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Placebo	PF-04950615 150 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	185 / 353 (52.41%)	205 / 356 (57.58%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	4 / 353 (1.13%)	1 / 356 (0.28%)
occurrences all number	4	1
Vascular disorders
Hypertension
subjects affected / exposed	11 / 353 (3.12%)	12 / 356 (3.37%)
occurrences all number	12	12
General disorders and administration site conditions
Chest pain
subjects affected / exposed	4 / 353 (1.13%)	2 / 356 (0.56%)
occurrences all number	4	2
Fatigue
subjects affected / exposed	5 / 353 (1.42%)	7 / 356 (1.97%)
occurrences all number	6	8
Injection site bruising
subjects affected / exposed	2 / 353 (0.57%)	5 / 356 (1.40%)
occurrences all number	3	9
Injection site erythema
subjects affected / exposed	3 / 353 (0.85%)	9 / 356 (2.53%)
occurrences all number	3	17
Injection site haemorrhage
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences all number	5	5
Injection site pain
subjects affected / exposed	4 / 353 (1.13%)	6 / 356 (1.69%)
occurrences all number	32	8
Injection site pruritus
subjects affected / exposed	0 / 353 (0.00%)	4 / 356 (1.12%)
occurrences all number	0	4
Injection site reaction
subjects affected / exposed	5 / 353 (1.42%)	42 / 356 (11.80%)
occurrences all number	7	175
Non-cardiac chest pain
subjects affected / exposed	5 / 353 (1.42%)	1 / 356 (0.28%)
occurrences all number	7	1
Pain
subjects affected / exposed	5 / 353 (1.42%)	0 / 356 (0.00%)
occurrences all number	5	0
Reproductive system and breast disorders
Benign prostatic hyperplasia
Additional description: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.
subjects affected / exposed ^[2]	3 / 224 (1.34%)	1 / 221 (0.45%)
occurrences all number	3	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	3 / 353 (0.85%)	6 / 356 (1.69%)
occurrences all number	3	7
Cough
subjects affected / exposed	9 / 353 (2.55%)	8 / 356 (2.25%)
occurrences all number	10	8
Dyspnoea
subjects affected / exposed	6 / 353 (1.70%)	3 / 356 (0.84%)
occurrences all number	6	3
Sleep apnoea syndrome
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences all number	2	4
Psychiatric disorders
Anxiety
subjects affected / exposed	5 / 353 (1.42%)	1 / 356 (0.28%)
occurrences all number	5	1
Depression
subjects affected / exposed	3 / 353 (0.85%)	6 / 356 (1.69%)
occurrences all number	3	6
Investigations
Alanine aminotransferase increased
subjects affected / exposed	4 / 353 (1.13%)	0 / 356 (0.00%)
occurrences all number	4	0
Blood cortisol decreased
subjects affected / exposed	5 / 353 (1.42%)	6 / 356 (1.69%)
occurrences all number	5	7
Blood creatine phosphokinase increased
subjects affected / exposed	4 / 353 (1.13%)	3 / 356 (0.84%)
occurrences all number	4	3
Gamma-glutamyltransferase increased
subjects affected / exposed	6 / 353 (1.70%)	1 / 356 (0.28%)
occurrences all number	6	1
Vitamin D decreased
subjects affected / exposed	3 / 353 (0.85%)	5 / 356 (1.40%)
occurrences all number	3	5
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences all number	2	4
Fall
subjects affected / exposed	13 / 353 (3.68%)	10 / 356 (2.81%)
occurrences all number	13	11
Muscle strain
subjects affected / exposed	1 / 353 (0.28%)	5 / 356 (1.40%)
occurrences all number	1	6
Cardiac disorders
Angina pectoris
subjects affected / exposed	4 / 353 (1.13%)	5 / 356 (1.40%)
occurrences all number	4	5
Palpitations
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences all number	2	5
Nervous system disorders
Dizziness
subjects affected / exposed	12 / 353 (3.40%)	1 / 356 (0.28%)
occurrences all number	12	1
Headache
subjects affected / exposed	14 / 353 (3.97%)	8 / 356 (2.25%)
occurrences all number	14	8
Hypoaesthesia
subjects affected / exposed	4 / 353 (1.13%)	1 / 356 (0.28%)
occurrences all number	4	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	4 / 353 (1.13%)	4 / 356 (1.12%)
occurrences all number	4	4
Constipation
subjects affected / exposed	4 / 353 (1.13%)	8 / 356 (2.25%)
occurrences all number	5	8
Diarrhoea
subjects affected / exposed	6 / 353 (1.70%)	12 / 356 (3.37%)
occurrences all number	7	13
Dyspepsia
subjects affected / exposed	4 / 353 (1.13%)	1 / 356 (0.28%)
occurrences all number	4	1
Gastrooesophageal reflux disease
subjects affected / exposed	5 / 353 (1.42%)	3 / 356 (0.84%)
occurrences all number	5	3
Nausea
subjects affected / exposed	7 / 353 (1.98%)	7 / 356 (1.97%)
occurrences all number	8	9
Vomiting
subjects affected / exposed	5 / 353 (1.42%)	4 / 356 (1.12%)
occurrences all number	5	7
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	4 / 353 (1.13%)	3 / 356 (0.84%)
occurrences all number	4	3
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	7 / 353 (1.98%)	13 / 356 (3.65%)
occurrences all number	8	15
Back pain
subjects affected / exposed	8 / 353 (2.27%)	15 / 356 (4.21%)
occurrences all number	9	17
Muscle spasms
subjects affected / exposed	8 / 353 (2.27%)	4 / 356 (1.12%)
occurrences all number	9	5
Musculoskeletal pain
subjects affected / exposed	5 / 353 (1.42%)	7 / 356 (1.97%)
occurrences all number	5	7
Myalgia
subjects affected / exposed	9 / 353 (2.55%)	8 / 356 (2.25%)
occurrences all number	9	9
Osteoarthritis
subjects affected / exposed	3 / 353 (0.85%)	5 / 356 (1.40%)
occurrences all number	3	5
Pain in extremity
subjects affected / exposed	11 / 353 (3.12%)	5 / 356 (1.40%)
occurrences all number	12	5
Tendonitis
subjects affected / exposed	2 / 353 (0.57%)	4 / 356 (1.12%)
occurrences all number	2	4
Infections and infestations
Acute sinusitis
subjects affected / exposed	3 / 353 (0.85%)	5 / 356 (1.40%)
occurrences all number	4	5
Bronchitis
subjects affected / exposed	14 / 353 (3.97%)	13 / 356 (3.65%)
occurrences all number	16	13
Cellulitis
subjects affected / exposed	4 / 353 (1.13%)	2 / 356 (0.56%)
occurrences all number	4	2
Gastroenteritis
subjects affected / exposed	8 / 353 (2.27%)	2 / 356 (0.56%)
occurrences all number	8	2
Herpes zoster
subjects affected / exposed	3 / 353 (0.85%)	4 / 356 (1.12%)
occurrences all number	3	4
Influenza
subjects affected / exposed	7 / 353 (1.98%)	10 / 356 (2.81%)
occurrences all number	7	13
Nasopharyngitis
subjects affected / exposed	27 / 353 (7.65%)	26 / 356 (7.30%)
occurrences all number	32	31
Pharyngitis
subjects affected / exposed	3 / 353 (0.85%)	6 / 356 (1.69%)
occurrences all number	5	6
Pneumonia
subjects affected / exposed	1 / 353 (0.28%)	8 / 356 (2.25%)
occurrences all number	1	8
Rhinitis
subjects affected / exposed	1 / 353 (0.28%)	4 / 356 (1.12%)
occurrences all number	1	4
Sinusitis
subjects affected / exposed	5 / 353 (1.42%)	10 / 356 (2.81%)
occurrences all number	5	10
Upper respiratory tract infection
subjects affected / exposed	19 / 353 (5.38%)	14 / 356 (3.93%)
occurrences all number	23	17
Urinary tract infection
subjects affected / exposed	6 / 353 (1.70%)	11 / 356 (3.09%)
occurrences all number	6	14
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	3 / 353 (0.85%)	4 / 356 (1.12%)
occurrences all number	3	4
Hypoglycaemia
subjects affected / exposed	4 / 353 (1.13%)	5 / 356 (1.40%)
occurrences all number	4	6
Type 2 diabetes mellitus
subjects affected / exposed	5 / 353 (1.42%)	4 / 356 (1.12%)
occurrences all number	5	4
Vitamin D deficiency
subjects affected / exposed	36 / 353 (10.20%)	19 / 356 (5.34%)
occurrences all number	36	19

Notes
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

19 Jun 2014

1. Reduced treatment duration from 80 to 52 weeks; reduced study follow-up period from 8 to 6 weeks. 2. Classified VLDL-C as a secondary endpoint rather than an exploratory endpoint.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3 Double-blind,Randomized, Placebo-Controlled,Parallel-Group Study to Assess The Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia

Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

Secondary: Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52

Secondary: Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Secondary: Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Secondary: Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

Secondary: Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

Secondary: Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Secondary: Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Other pre-specified: Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

Other pre-specified: Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3 Double-blind,Randomized, Placebo-Controlled,Parallel-Group Study to Assess The Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events