A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Inclusion Criteria:

• adult patients, 18-75 years of age;
• CHD or CHD risk equivalent;
• appropriately treated for accepted LDL-C level.

Exclusion Criteria:

• treatment with drugs raising HDL-C (eg niacin, fibrates);
• uncontrolled hypertension;
• recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
• severe anemia;
• poorly controlled diabetes.