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

Roche

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease

Treatments: Drug: dalcetrapib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655538

BC21144

2007-003406-10

Details and patient eligibility

About

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.

Enrollment: 476 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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476 participants in 2 patient groups, including a placebo group

Dalcetrapib

Experimental group

Treatment:

Drug: dalcetrapib

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo