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

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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 15,600 individuals.

Key facts

Study ID

NCT00658515

Run by

Hoffmann-La Roche

People needed

15871

Starts

2008-04-01

Expected to finish

2012-09-01

Last updated by the study team

2020-01-03

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, >=45 years of age;
• recently hospitalized for ACS;
• clinically stable;
• receiving evidence-based medical and dietary management of dyslipidemia.

You may not qualify if…

• uncontrolled diabetes;
• clinically unstable;
• severe anemia;
• uncontrolled hypertension;
• concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Lake Havasu City, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Mountain Home, Arkansas, United States
• Study site — Searcy, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Bellflower, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Buena Park, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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