A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

Phase 2

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Placebo; Drug: dalcetrapib

• Registration Number: NCT00655538
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Results First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dalcetrapib	dalcetrapib	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in % Flow Mediated Dilatation (FMD)	Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
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