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A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
Details
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 613 |
| Start date | 2006-03 |
Conditions
- Mixed Dyslipidemia
- Coronary Heart Disease
- Dyslipidemia
Interventions
- ABT-335
- Atorvastatin
- Placebo
Primary outcomes
- Mean Percent Change in Triglycerides From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100 - Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100 - Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit — Baseline to 12 Weeks (Final Visit)
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
Countries
United States