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

Phase 1

• Conditions: Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease; MedDRA version: 9.1Level: LLTClassification code 10003601Term: Atherosclerosis

• Registration Number: EUCTR2007-005839-28-FR
• Lead Sponsor: aboratoires Merck Sharp & Dhome-Chibret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-11
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Patient is male or female and =18 and =80 years of age on day of signing informed consent.

2. Based on NCEP ATP III guidelines, the patient has
CHD/CHD risk-equivalent disease (including diabetes) and LDL-C <100 mg/dL
(2.59 mmol/L).

3. Patient is treated with statin ± other lipid-modifying therapy and has HDL-C <60 mg/dL (1.55 mmol/L).

4. Patient has triglyceride (TG) concentrations =400 mg/dL (4.52 mmol/L).
5. A patient who is of reproductive potential agrees to remain abstinent* or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV.

2. Patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke MI within 3 months prior to Visit 1.

3. LDL-C <50 mg/dL (1.29 mmol/L).

4. Patient has uncontrolled hypertension defined as follows:
•Sitting diastolic blood pressure =100 mmHg, or sitting systolic blood pressure =160 mm Hg (non-diabetic patients).
OR
•Sitting diastolic blood pressure =90 mmHg, or sitting systolic blood pressure =150 mm Hg (diabetic patients).

5. Patient has exclusionary laboratory values as listed below:
• CPK (creatine phosphokinase) >2 x upper limit of normal (ULN) [per central laboratory reference ranges].
• ALT (alanine aminotransferase), or AST (aspartate aminotransferase) >2x upper limit of normal (ULN) [per central laboratory reference ranges].

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified