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

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	8/3/2016
Start Date:	March 2008
End Date:	November 2010

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

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.

Inclusion Criteria:

- adult patients, 18-75 years of age;

- CHD, including patients with other CHD risk factors;

- treated appropriately for dyslipidemia;

- clinically stable.

Exclusion Criteria:

- 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.

We found this trial at

sites

Clinical Trial Facility in Cincinnati Ohio

Cincinnati, Ohio

from

Cincinnati, OH