A Study to Assess the Tolerability and Effectiveness of MK-0859 (Anacetrapib) when Added to Ongoing Statin Therapy 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
- Coronary Heart Disease (CHD) or CHD Risk-Equivalent DiseaseMedDRA version: 14.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-005839-28-SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
None.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main Objective:<br>In patients with CHD/CHD risk-equivalent disease who were previously treated with anacetrapib during the DEFINE P019 study:<br>To assess the plasma levels of anacetrapib remaining in patients who were previously treated with anacetrapib;Secondary Objective: Exploratory Objective:<br>To assess LDL-C and HDL-C levels in patients who were previously treated with anacetrapib;Primary end point(s): Safety and tolerability of anacetrapib 100 mg; <br>elevations in safety laboratory variables<br>elevations in blood pressure <br>myalgia, rhabdomyolysis<br>Pre-specified adjudicated CV serious adverse events<br>Death;Timepoint(s) of evaluation of this end point: Following 104 weeks of the 2-year extension.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): LDL-C, HDL-C, non-HDL-C, apo-B, apo A-I, TC, TG, TC/HDLC,<br>LDL-C/HDL-C , LDL-C/Apo B, Apo B/ ApoA-I, lp(a), apo E , CETP mass, CETP activity and hsCRP, and percent change from baseline (Day 0; Visit 3 in the base study);Timepoint(s) of evaluation of this end point: Following 104 weeks of the 2-year extension.