Conditions: Cardiovascular Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 936
Healthy volunteers: no

Brief summary:
This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dalcetrapib intervention 2: Placebo
Intervention descriptions: intervention 1: Dalcetrapib 600 mg orally once daily intervention 2: Placebo orally once daily

Protocol document: