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Clinical
Research Study
Mercy St. Vincent Medical Center
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A Study of RO4607381 in Stable Coronary Heart Disease Patients
With Recent Acute Coronary Syndrome
Sponsored by: Hoffmann-La Roche, October 2008
Purpose
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.
Eligibility
| Ages Eligible for Study: |
45 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
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).
Contacts
Physicians:
Ameer Kabour, MD
Mohammad Alkhateeb, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Coordinators:
Brenda Hoagland, RN, CCRC
Michelle Hickam, BSN
Julie Neidhardt, BSN
Please contact us at 419-251-4919 for more information about this study.
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