drugset / Trial / NCT00353522

A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

NCT00353522

Phase 2 Completed 135 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Dalcetrapib Small molecule 900 mg Oral