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.

Hoffmann-La Roche0 sites476 target enrollmentFebruary 2008

ConditionsCoronary Heart Disease

Interventionsdalcetrapib Placebo

DrugsPlacebo dalcetrapib

Overview

Phase: Phase 2
Intervention: dalcetrapib
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Enrollment: 476
Primary Endpoint: Change From Baseline in % Flow Mediated Dilatation (FMD)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

May 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Intervention: dalcetrapib

Placebo

Intervention: Placebo

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)