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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01059682

Run by

Hoffmann-La Roche

People needed

936

Starts

2010-01-01

Expected to finish

2011-09-01

Last updated by the study team

2020-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients over the age of 18 years
• Angiographic evidence of coronary artery disease
• Ultrasound evidence of carotid artery disease
• Treated appropriately for dyslipidemia

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Torrance, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Greeley, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Elkhart, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Columbia, Maryland, United States
• Study site — Salisbury, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Midland, Michigan, United States
• Study site — Muskegon, Michigan, United States
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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