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

NCT00658515

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Coronary Heart Disease

Interventions: Dalcetrapib (RO4607381), Evidence-based medical care for Acute Coronary Syndrome, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 45 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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).
Locations (1089)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Tuscaloosa, Alabama, United States
  • Lake Havasu City, Arizona, United States
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Scottsdale, Arizona, United States
  • Sierra Vista, Arizona, United States
  • Tempe, Arizona, United States
  • Tucson, Arizona, United States
  • Hot Springs, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Mountain Home, Arkansas, United States
  • Searcy, Arkansas, United States
  • Anaheim, California, United States
  • Bakersfield, California, United States
  • Bellflower, California, United States
  • Beverly Hills, California, United States
  • Buena Park, California, United States
  • Burbank, California, United States
  • Carmichael, California, United States
  • Corona, California, United States
  • Costa Mesa, California, United States
  • Encinitas, California, United States
  • + 1059 more on CT.gov