A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Dalcetrapib

Criteria

Inclusion Criteria:

• Adult patients over the age of 18 years

• Angiographic evidence of coronary artery disease

• Ultrasound evidence of carotid artery disease

• Treated appropriately for dyslipidemia

Exclusion Criteria:

• Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or CETP-vaccine within the last 3 months before study start

• Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months

• Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization

• Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV)

• Severe anemia

• Uncontrolled hypertension

• Poorly controlled diabetes