Last reviewed · How we verify
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
Details
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1445 |
| Start date | 2006-03 |
Conditions
- Dyslipidemia
- Coronary Heart Disease
- Mixed Dyslipidemia
Interventions
- ABT-335
- Rosuvastatin Calcium
- Placebo
Primary outcomes
- Mean Percent Change in Triglycerides From Baseline to Final Visit — Baseline to 12 Weeks
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100 - Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit — Baseline to 12 Weeks
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100 - Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit — Baseline to 12 Weeks
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
Countries
United States