Conditions: Dyslipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 292
Healthy volunteers: no

Brief summary:
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Placebo intervention 2: Pravastatin intervention 3: Dalcetrapib intervention 4: Dalcetrapib intervention 5: Dalcetrapib
Intervention descriptions: intervention 1: po daily for 12 weeks intervention 2: 40mg po daily for 12 weeks intervention 3: 300mg po daily for 12 weeks intervention 4: 600mg po daily for 12 weeks intervention 5: 900mg po daily for 12 weeks

Protocol document: