drugset / Trial / NCT00353522
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalcetrapib | Small molecule | 900 mg | Oral |