Trial Information

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

Status: Not yet recruiting

Protocol Number: BC21144

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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.

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. Target sample size is 450.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Coronary Heart Disease

Intervention Type: Drug

Intervention Name: RO4607381

Primary Outcome: 1. Change from baseline in % flow mediated dilatation (FMD) Time frame: 12 weeks 2. Change from baseline in mean BP, measured by BP monitoring Time frame: 4 weeks

Key Secondary Outcomes: 1. Change from baseline in % FMD Time frame: 36 weeks 2. Blood lipids, lipoproteins Time frame: Throughout study 3. CETP mass and activity Time frame: Up to 36 weeks 4. Biomarkers Time frame: Up to 36 weeks 5. Change from baseline in mean BP, measured by BP monitoring Time frame: Up to 36 weeks 6. AEs, lab parameters, vital signs, ECG Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2008

Trial Registration Date: 03/28/2008

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 2:49:14 PM