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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Coronary Artery Disease
Trial Information
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 25530.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
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:
- adult patients, >=45 years of age;
- recently hospitalized for ACS;
- clinically stable;
- receiving evidence-based medical and dietary management of dyslipidemia.
Exclusion Criteria:
- uncontrolled diabetes;
- clinically unstable;
- severe anemia;
- uncontrolled hypertension;
- concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
BrasÃlia 70310-500
Brazil
Phone: 973-235-5000 or 800-526-6367
View Google Map
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