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
Phase 1
- Conditions
- Hypercholesterolemia, mixed hyperlipidemiaMedDRA version: 14.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-005839-28-AT
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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.
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 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
Exclusion Criteria
for PN019-06: None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method