drugset / Trial / NCT00697203
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2006-05
- Completion
- 2006-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalcetrapib | Small molecule | 300 mg | Oral |
| Subject | Dalcetrapib | Small molecule | 600 mg | Oral |
| Subject | Dalcetrapib | Small molecule | 900 mg | Oral |
| Background | Pravastatin | Small molecule | 40 mg | Oral |