A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Key facts

Study ID

NCT00655473

Run by

Hoffmann-La Roche

People needed

130

Starts

2008-03-01

Expected to finish

2010-11-01

Last updated by the study team

2020-01-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• CHD, including patients with other CHD risk factors;
• treated appropriately for dyslipidemia;
• clinically stable.

You may not qualify if…

• previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
• recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
• severe anemia;
• uncontrolled hypertension;
• poorly controlled diabetes.

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — New York, New York, United States
• Study site — Statesville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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