Conditions: Coronary Heart Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15871
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dalcetrapib (RO4607381) intervention 2: Evidence-based medical care for Acute Coronary Syndrome intervention 3: Placebo
Intervention descriptions: intervention 1: 600mg po daily intervention 2: As prescribed intervention 3: po daily

Protocol document: