Status:
COMPLETED
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be ...
Eligibility Criteria
Inclusion
- adult patients, 18-75 years of age;
- CHD or CHD risk equivalent;
- body weight \<125kg at visit 1.
Exclusion
- recent (within 3 weeks of screening) clinically significant coronary events;
- history of statin-associated myopathy, or intolerance to statin;
- history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
- exposure to RO4607381 in past 12 months.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00353522
Start Date
July 1 2006
End Date
October 1 2008
Last Update
January 27 2020
Active Locations (17)
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1
Chicago, Illinois, United States, 60610
2
Indianapolis, Indiana, United States, 46260
3
Iowa City, Iowa, United States, 52242
4
Louisville, Kentucky, United States, 40213