Trial Information

Summary: A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Status: Recruiting

Protocol Number: NC20971

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind, placebo-controlled study assessing the effect of RO4607381 on cardiovascular mortality and morbidity in clinically stable patients with a recent acute coronary syndrome

Brief Summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 15600.

Study Phase: III

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. Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) Time frame: Event driven

Key Secondary Outcomes: 1. Composite endpoint:all cause mortality Time frame: Event driven 2. Change from baseline in blood lipids and lipoprotein levels Time frame: Throughout study 3. Adverse events, lab parameters, vital signs, ECG Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 45 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2008

Trial Registration Date: 03/28/2008

Date Last Updated: 10/28/2008

Link To Trial Results

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Trial listings updated: December 2, 2008 at 3:15:46 PM