At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years
- ✓Coronary heart disease or CHD risk equivalent
- ✓Body weight <125 kg at screening
- ✕Clinically significant coronary event within 3 weeks of screening
- ✕History of statin-associated myopathy or statin intolerance
- ✕Malignancy within 3 years (except treated skin cancer)
- ✕Prior exposure to RO4607381 within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent
In Brief
A Phase 2 clinical trial evaluating Placebo and dalcetrapib for Coronary Heart Disease. Completed, enrolled 135 participants across 17 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
po daily for 24 weeks
900mg po daily for 24 weeks