Conditions: Coronary Heart Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dalcetrapib (RO4607381) intervention 2: Placebo
Intervention descriptions: intervention 1: 600mg po daily for 24 months intervention 2: po daily for 24 months

Protocol document: