Conditions: Coronary Heart Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Dalcetrapib 900mg po daily for 24 weeks arm 2: Placebo po daily for 24 weeks

Interventions: intervention 1: Placebo intervention 2: dalcetrapib
Intervention descriptions: intervention 1: po daily for 24 weeks intervention 2: 900mg po daily for 24 weeks

Protocol document: