A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Dalcetrapib

Criteria

Inclusion Criteria:

• adult patients, >=45 years of age;

• recently hospitalized for ACS;

• clinically stable;

• receiving evidence-based medical and dietary management of dyslipidemia.

Exclusion Criteria:

• uncontrolled diabetes;

• clinically unstable;

• severe anemia;

• uncontrolled hypertension;

• concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).