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Clinical Trial Results:
Dose-Ranging Pharmacodynamic Assessment Of Platelet Aggregation Inhibition With Clopidogrel In Children Of Blalock-Taussing Shunt Age Categories (Neonates And Infants/Toddlers)

Summary
EudraCT number	2004-001841-14
Trial protocol	IT BE Outside EU/EEA
Global end of trial date	15 Apr 2006

Results information
Results version number	v2(current)
This version publication date	07 Jul 2016
First version publication date	03 Jun 2015
Other versions	v1
Version creation reason	Correction of full data set Typo corrections

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

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Trial information

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Sponsor protocol code

PDY4422

ISRCTN number

US NCT number

NCT00115375

WHO universal trial number (UTN)

Sponsor organisation name

Sanofi aventis recherche & développement

Sponsor organisation address

1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380

Public contact

Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com

Scientific contact

Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000049-PIP01-07

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

Yes

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

Analysis stage

Final

Date of interim/final analysis

16 May 2006

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Apr 2006

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to determine the dose of clopidogrel to achieve a mean 30 to 50% inhibition of 5 micromole adenosine diphosphate (ADP)-induced platelet aggregation (that is, to provide inhibition of platelet aggregation similar to that observed with 75 mg in adults) in neonates and infants/Toddlers at risk for thrombosis.

Protection of trial subjects

The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), was provided and explained. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn was adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.

Background therapy

Evidence for comparator

Actual start date of recruitment

13 Jan 2004

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Italy: 2

Country: Number of subjects enrolled

Belgium: 8

Country: Number of subjects enrolled

United States: 42

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

France: 12

Country: Number of subjects enrolled

Germany: 26

Worldwide total number of subjects

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 22 centers in 6 countries between 13 January 2004 and 15 April 2006.

Screening details

After written informed consent was obtained from the parent or guardian, subjects were randomly assigned to clopidogrel versus placebo in a 3:1 ratio in 4 sequential groups (0.01, 0.10, 0.20, and 0.15 mg/kg). Subjects were also stratified by age: neonates <=30 days old and infant/toddlers >30 days to 24 months old.

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, Assessor

Blinding implementation details

The clopidogrel and placebo (mannitol powder) were identical in appearance and consistency and both were reconstituted in the same fashion thus there was no way of identifying the treatment.

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo once daily for at least 7 consecutive days (up to a maximum of 28 days).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for oral solution

Routes of administration

Oral use

Dosage and administration details

Oral solution administered with a syringe orally or via enteric administration.

Clopidogrel 0.01 mg/kg

Arm description

Clopidogrel 0.01 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Arm type

Experimental

Investigational medicinal product name

Clopidogrel

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for oral solution

Routes of administration

Oral use

Dosage and administration details

0.01 mg/kg in oral solution administered with a syringe orally or via enteric administration.

Clopidogrel 0.1 mg/kg

Arm description

Clopidogrel 0.1 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Arm type

Experimental

Investigational medicinal product name

Clopidogrel

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for oral solution

Routes of administration

Oral use

Dosage and administration details

0.1 mg/kg in oral solution administered with a syringe orally or via enteric administration.

Clopidogrel 0.15 mg/kg

Arm description

Clopidogrel 0.15 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Arm type

Experimental

Investigational medicinal product name

Clopidogrel

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for oral solution

Routes of administration

Oral use

Dosage and administration details

0.15 mg/kg in oral solution administered with a syringe orally or via enteric administration.

Clopidogrel 0.2 mg/kg

Arm description

Clopidogrel 0.2 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Arm type

Experimental

Investigational medicinal product name

Clopidogrel

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for oral solution

Routes of administration

Oral use

Dosage and administration details

0.2 mg/kg in oral solution administered with a syringe orally or via enteric administration.

Number of subjects in period 1	Placebo	Clopidogrel 0.01 mg/kg	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg
Started	23	12	21	10	26
Treated	21	10	21	8	26
Completed	16	9	19	7	25
Not completed	7	3	2	3	1
Randomized but not treated	2	2	-	2	-
Adverse event	2	-	1	-	-
Bleeding	1	1	-	-	-
Unspecified	2	-	1	1	1

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Placebo once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.01 mg/kg

Reporting group description

Clopidogrel 0.01 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.1 mg/kg

Reporting group description

Clopidogrel 0.1 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.15 mg/kg

Reporting group description

Clopidogrel 0.15 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.2 mg/kg

Reporting group description

Clopidogrel 0.2 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group values	Placebo	Clopidogrel 0.01 mg/kg	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg	Total
Number of subjects	23	12	21	10	26	92
Age categorical
Units: Subjects
Neonates (<= 30 days)	11	5	10	10	9	45
Infant/Toddler (1 - 24 months)	12	7	11	0	17	47
Gender categorical
Units: Subjects
Female	7	7	5	4	12	35
Male	16	5	16	6	14	57

End points

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Reporting group title

Placebo

Reporting group description

Placebo once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.01 mg/kg

Reporting group description

Clopidogrel 0.01 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.1 mg/kg

Reporting group description

Clopidogrel 0.1 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.15 mg/kg

Reporting group description

Clopidogrel 0.15 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Reporting group title

Clopidogrel 0.2 mg/kg

Reporting group description

Clopidogrel 0.2 mg/kg once daily for at least 7 consecutive days (up to a maximum of 28 days).

Primary: Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

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End point title

Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

End point description

Analysis was carried out on per protocol (PP) population defined as all randomized and treated subjects who had a baseline and a steady state assessment of platelet aggregation.

End point type

Primary

End point timeframe

Baseline, Steady State (Day 7-28)

End point values	Placebo	Clopidogrel 0.01 mg/kg	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg
Number of subjects analysed	16 ^[1]	8 ^[2]	18 ^[3]	6 ^[4]	25 ^[5]
Units: percent inhibition
arithmetic mean (standard deviation)	0.8 ( 48 )	-12.8 ( 46.2 )	18.9 ( 40.4 )	36.4 ( 27.5 )	49.3 ( 27.2 )

Notes
[1] - 7 neonates and 9 infants/toddlers
[2] - 3 neonates and 5 infants/toddlers
[3] - 8 neonates and 10 infants/toddlers
[4] - 6 neonates only (no infant/toddler)
[5] - 10 neonates and 15 infants/toddlers

Clopidogrel 0.01 mg/kg vs Placebo

Statistical analysis description

ANOVA was performed on percent inhibition of maximum extent of aggregation with model terms for treatment group, age group, and the treatment group–by–age group interaction. The differences between active-dose level and placebo were estimated within the ANOVA framework with 95% confidence intervals.

Comparison groups

Placebo v Clopidogrel 0.01 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4445 ^[6]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

-12.28

Confidence interval

level

95%

sides

2-sided

lower limit

-44.16

upper limit

19.59

Notes
[6] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.1 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.1 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1602 ^[7]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

17.99

Confidence interval

level

95%

sides

2-sided

lower limit

-7.29

upper limit

43.26

Notes
[7] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.15 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.15 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2139 ^[8]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

20.94

Confidence interval

level

95%

sides

2-sided

lower limit

-12.76

upper limit

54.65

Notes
[8] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.2 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.2 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001 ^[9]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

49.26

Confidence interval

level

95%

sides

2-sided

lower limit

25.7

upper limit

72.82

Notes
[9] - Statistical significance was claimed if the computed p-value was ≤0.05.

Primary: Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

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End point title

Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

End point description

Analysis was performed on PP population as previously defined.

End point type

Primary

End point timeframe

Baseline, Steady State (Day 7-28)

End point values	Placebo	Clopidogrel 0.01 mg/kg	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg
Number of subjects analysed	16 ^[10]	8 ^[11]	18 ^[12]	6 ^[13]	25 ^[14]
Units: percent inhibition
arithmetic mean (standard deviation)	-9.6 ( 35 )	-1.6 ( 28 )	0.8 ( 57.7 )	33.7 ( 28.2 )	33.8 ( 31.6 )

Notes
[10] - 7 neonates and 9 infants/toddlers
[11] - 3 neonates and 5 infants/toddlers
[12] - 8 neonates and 10 infants/toddlers
[13] - 6 neonates only (no infant/toddler)
[14] - 10 neonates and 15 infants/toddlers

Clopidogrel 0.01 mg/kg vs Placebo

Statistical analysis description

ANOVA was performed on percent inhibition of rate of aggregation with model terms for treatment group, age group, and the treatment group–by–age group interaction. The differences between active-dose level and placebo were estimated within the ANOVA framework with 95% confidence intervals.

Comparison groups

Placebo v Clopidogrel 0.01 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.61 ^[15]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

8.8

Confidence interval

level

95%

sides

2-sided

lower limit

-25.47

upper limit

43.07

Notes
[15] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.1 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.1 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.455 ^[16]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

10.23

Confidence interval

level

95%

sides

2-sided

lower limit

-16.94

upper limit

37.4

Notes
[16] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.15 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.15 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1063 ^[17]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

36.49

Confidence interval

level

95%

sides

2-sided

lower limit

-8.28

upper limit

81.27

Notes
[17] - Statistical significance was claimed if the computed p-value was ≤0.05.

Clopidogrel 0.2 mg/kg vs Placebo

Comparison groups

Placebo v Clopidogrel 0.2 mg/kg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0009 ^[18]

Method

ANOVA

Parameter type

Mean difference (final values)

Point estimate

43.89

Confidence interval

level

95%

sides

2-sided

lower limit

18.56

upper limit

69.22

Notes
[18] - Statistical significance was claimed if the computed p-value was ≤0.05.

Adverse events

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Timeframe for reporting adverse events

Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 7-28) regardless of seriousness or relationship to investigational product.

Adverse event reporting additional description

Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during the ‘on treatment period’ (from first study drug administration up to final visit).”

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

8.1

Reporting group title

Clopidogrel 0.01 mg/kg

Reporting group description

Subjects exposed to clopidogrel 0.01 mg/kg.

Reporting group title

Placebo

Reporting group description

Subjects exposed to placebo.

Reporting group title

Clopidogrel 0.1 mg/kg

Reporting group description

Subjects exposed to clopidogrel 0.1 mg/kg

Reporting group title

Clopidogrel 0.15 mg/kg

Reporting group description

Subjects exposed to clopidogrel 0.15 mg/kg.

Reporting group title

Clopidogrel 0.2 mg/kg

Reporting group description

Subjects exposed to clopidogrel 0.2 mg/kg.

Serious adverse events	Clopidogrel 0.01 mg/kg	Placebo	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 10 (10.00%)	2 / 21 (9.52%)	0 / 21 (0.00%)	1 / 8 (12.50%)	1 / 26 (3.85%)
number of deaths (all causes)	0	0	0	1	0
number of deaths resulting from adverse events
Investigations
Desaturation
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Desaturations
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	1 / 26 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Low Platelet Count
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Shunt Thrombosis
subjects affected / exposed	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Cardiac disorders
Bradycardia
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Heart Failure (Worsening)
subjects affected / exposed	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Sepsis (Suspicion)
subjects affected / exposed	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Clopidogrel 0.01 mg/kg	Placebo	Clopidogrel 0.1 mg/kg	Clopidogrel 0.15 mg/kg	Clopidogrel 0.2 mg/kg
Total subjects affected by non serious adverse events
subjects affected / exposed	6 / 10 (60.00%)	3 / 21 (14.29%)	4 / 21 (19.05%)	6 / 8 (75.00%)	1 / 26 (3.85%)
Investigations
Desaturation Without Hemodynamic Change
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Symmetric Pulmonary Opacity
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Injury, poisoning and procedural complications
Overdose Of Study Medication
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Study Drug Overdosage
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
General disorders and administration site conditions
Fever
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	0	0	0	0
Irritability
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	0	0	0	0
Gastrointestinal disorders
Diarrhea
subjects affected / exposed	0 / 10 (0.00%)	1 / 21 (4.76%)	2 / 21 (9.52%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	1	2	1	0
Emesis
subjects affected / exposed	2 / 10 (20.00%)	2 / 21 (9.52%)	2 / 21 (9.52%)	0 / 8 (0.00%)	1 / 26 (3.85%)
occurrences all number	2	2	2	0	1
Emesis - Intermittent
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	0	0	0	0
Gastrointestinal Bleeding
subjects affected / exposed	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	1	0	0	0
Stomach Ache
subjects affected / exposed	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	1	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Hypoxia
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Upper Airway Congestion
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Skin and subcutaneous tissue disorders
Exacerbation Of Diaper Rash
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Rash
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	0	0	0	0
Renal and urinary disorders
Hematuria Bleeding
subjects affected / exposed	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	0 / 8 (0.00%)	0 / 26 (0.00%)
occurrences all number	1	0	0	0	0
Infections and infestations
Thrush
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0
Urinary Tract Infection
subjects affected / exposed	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 21 (0.00%)	1 / 8 (12.50%)	0 / 26 (0.00%)
occurrences all number	0	0	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

09 May 2003

Stepwise approach for blood sampling extended to subjects of 3 to 5 kg body weight according to Investigator’s judgment. Eligibility of enrollment of any subject with systemic to pulmonary artery shunts in addition to the Blalock-Taussig shunt subject populations. Update of “introduction and rationale” with results of the Phase 1 bioavailability study of the liquid formulation. Shunt replacement was recorded in addition to other clinical outcomes in event rate documentation for planning the Phase 3 efficacy and safety study. Since this information was collected in an anonymous fashion, no informed consent was required for this type of data collection. Update of instructions for platelet aggregation testing and pharmacokinetic blood sample handling as per lab manual technical revisions.

02 Apr 2004

Clarification on the protocol: - Neonates eligible for the study are less than 30 days; - Eligibility of enrollment of any subject who may have potential therapeutic benefits from clopidogrel because of a related pathological condition requiring antiplatelet therapy (such as but not limited to Kawaski disease, vascular stent, Glenn shunt or Fontan physiology); - Stepwise approach for blood sampling extended, according to Investigator’s judgment, to any subject without reliable vascular access (that is, difficult venipuncture, lack of central venous line or indwelling catheter) to limit the number of blood withdrawals while preserving the primary objective of the study (pharmacodynamic).

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

http://www.ncbi.nlm.nih.gov/pubmed/18195173

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Clinical Trial Results:
Dose-Ranging Pharmacodynamic Assessment Of Platelet Aggregation Inhibition With Clopidogrel In Children Of Blalock-Taussing Shunt Age Categories (Neonates And Infants/Toddlers)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

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Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: Dose-Ranging Pharmacodynamic Assessment Of Platelet Aggregation Inhibition With Clopidogrel In Children Of Blalock-Taussing Shunt Age Categories (Neonates And Infants/Toddlers)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Maximum Extent of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

Primary: Percent Inhibition of Rate of 5 µmol/L ADP-Induced Platelet Aggregation

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Dose-Ranging Pharmacodynamic Assessment Of Platelet Aggregation Inhibition With Clopidogrel In Children Of Blalock-Taussing Shunt Age Categories (Neonates And Infants/Toddlers)