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

Hoffmann-La Roche476 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

476

Conditions

Coronary Heart Disease

Interventions

PlaceboDRUG

po daily for 36 weeks

dalcetrapibDRUG

600mg po daily for 36 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (23)

Unnamed facility

Feldkirch, Austria

Unnamed facility

Paris, France

Unnamed facility

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

Time frame: baseline and 36 weeks

Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB

Time frame: Baseline to 36 weeks

CETP Activity

Time frame: Up 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

Time frame: Baseline and 36 weeks

Change From Baseline in Mean BP, Measured by BP Monitoring

Time frame: Up to 36 weeks

Percent Change CETP Mass

Time frame: baseline to 36 weeks

Data from ClinicalTrials.gov

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