Status:
COMPLETED
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Lead Sponsor:
Abbott
Conditions:
Dyslipidemias
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe i...
Eligibility Criteria
Inclusion
- Subjects with mixed dyslipidemia (trigylcerides, \> or = to 150 mg/dL to \< 400 mg/dL; HDL-C \< 40 mg/dL for males, \< 50 mg/dL for females; LDL-C, \> or = to 130 mg/dL).
- Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.
Exclusion
- Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
- Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
- Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT00639158
Start Date
February 1 2008
Last Update
June 13 2011
Active Locations (118)
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1
Birmingham, Alabama, United States, 35209
2
Columbiana, Alabama, United States, 35051
3
Hueytown, Alabama, United States, 35023
4
Ozark, Alabama, United States, 36360