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
NCT00639158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 543
Last updated 2011-06-13
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 in subjects with abnormal lipid (fat) levels in the blood.
Conditions
- Dyslipidemias
- Coronary Heart Disease
- Combined (Atherogenic) Dyslipidemia
- Mixed Dyslipidemia
Interventions
- DRUG
-
ABT-335
135 mg capsule, daily, 12 weeks
- DRUG
-
placebo capsule, daily, 12 weeks
- DRUG
-
40 mg, tablet, daily, 12 weeks
- DRUG
-
ezetimibe
10 mg capsule, daily, 12 weeks
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2008-10-31
Countries
- United States
Study Locations
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