NCT00655538CompletedPhase 2
A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 476
- Primary Endpoint
- Change From Baseline in % Flow Mediated Dilatation (FMD)
Study Overview
Brief Summary
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients, 18-75 years of age;
- •CHD or CHD risk equivalent;
- •appropriately treated for accepted LDL-C level.
Exclusion Criteria
- •treatment with drugs raising HDL-C (eg niacin, fibrates);
- •uncontrolled hypertension;
- •recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
- •severe anemia;
- •poorly controlled diabetes.
Arms & Interventions
Dalcetrapib
Experimental
Intervention: dalcetrapib (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in % Flow Mediated Dilatation (FMD)
Time Frame: Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Time Frame: Baseline and 4 weeks
Secondary Outcomes
- Change From Baseline in % FMD(baseline and 36 weeks)
- Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB(Baseline to 36 weeks)
- CETP Activity(Up to 36 weeks)
- Change From Baseline in Mean BP, Measured by BP Monitoring(Up to 36 weeks)
- Percent Change CETP Mass(baseline to 36 weeks)
- Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9(Baseline and 36 weeks)
Investigators
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