Clinical Trials Register

Summary
EudraCT Number:	2007-005839-28
Sponsor's Protocol Code Number:	0859-019-06
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-03-11
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2007-005839-28

A.3

Full title of the trial

A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease: Evaluation of plasma anacetrapib concentrations, lipid levels and pregnancy outcomes (women of child-bearing potential) in patients who were previously treated with anacetrapib

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

Efficacy of Anacetrapib with Statin

A.4.1

Sponsor's protocol code number

0859-019-06

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck & Co., Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme GesmbH
B.5.2	Functional name of contact point	Clinical Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Am Euro Platz 2
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1120
B.5.3.4	Country	Austria
B.5.4	Telephone number	+43126044234
B.5.5	Fax number	+43126044406
B.5.6	E-mail	susanne.zottl@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	-
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Anacetrapib
D.3.2	Product code	MK-0859; L-001309643
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MK-0859; L-001309643-000D
D.3.9.3	Other descriptive name	Anacetrapib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hypercholesterolemia, mixed hyperlipidemia

E.1.1.1

Medical condition in easily understood language

Hypercholesterolemia, mixed hyperlipidemia

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10003601
E.1.2	Term	Atherosclerosis
E.1.2	System Organ Class	100000004866

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

PN019-00 to 04: Evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo on plasma concentrations of LDL-C.
PN019-10 and 11: To assess the safety and tolerability of anacetrapib 100 mg
PN019-12 and 14: (1) To assess the plasma levels of anacetrapib during the reversal period and to estimate the apparent terminal half-life (t1/2) of anacetrapib
(2) To assess the safety and tolerability during the 1-year reversal period following
cessation of anacetrapib
PN019-06: To assess the plasma levels of anacetrapib remaining in patients who were previously treated with anacetrapib

E.2.2

Secondary objectives of the trial

PN019-00 to 04 (3/5 objectives listed)
(1) Evaluate the effects of anacetrapib (100 mg) on HDL-C, non-HDL-C, apo-B, and apo A-I compared to placebo after 24 wks of treatment. (2) Evaluate effects of anacetrapib (100 mg) on LDL-C, HDL-C, non-HDL-C, apo-B, and apo A-I compared to placebo after 76 wks of treatment. (3) Evaluate the effects of anacetrapib (100 mg) on plasma levels of total cholesterol, triglycerides, LDL-C/HDL-C, apo B/apo A-1, LDL-C/apo B, lipoprotein and lipoprotein sub-fractions after 24 wks and 76 wks of treatment.
PN019-10 & 11: (2/3 objectives listed)
(1) To evaluate efficacy of anacetrapib (100 mg) on LDL-C, HDL-C, lipoprotein (a) [Lp(a)], non-HDL-C, apo-B, and apo A-I, compared to placebo. (2) To evaluate the efficacy of anacetrapib (100 mg) on plasma levels of total cholesterol, triglycerides, TC/HDL-C, LDL-C/HDL-C, apoB/apoA-I, and LDLC/apoB, lipoprotein, hs-CRP, apoE, CETP activity and CETP mass,compared to placebo.
PN019-12 & 06: no secondary objectives

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

for PN019-06:
(1) DEFINE study patients who took at least one dose of anacetrapib and are not currently enrolled in the ongoing PN 019-12 study.
(2) Patients who have completed or discontinued from the PN 019-12 study.
(3) Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.

E.4

Principal exclusion criteria

for PN019-06: None

E.5 End points

E.5.1

Primary end point(s)

For PN019-06, there are no efficacy endpoints as subjects are not on treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

see E.5.1

E.5.2

Secondary end point(s)

see E.5.1

E.5.2.1

Timepoint(s) of evaluation of this end point

see E.5.1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Austria

Canada

Colombia

Finland

France

Germany

Hong Kong

Hungary

Israel

Malaysia

Netherlands

New Zealand

Norway

Peru

Russian Federation

Spain

Sweden

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

250

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

All patients will be followed up 12 weeks after last dose of study drug. At this follow-up phone call any serious adverse experience, including death will be reported.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-04-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-04-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-11-23

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