NCT00639158
Completed
Phase 3
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia
Overview
- Phase
- Phase 3
- Intervention
- ABT-335
- Conditions
- Dyslipidemias
- Sponsor
- Abbott
- Enrollment
- 543
- Primary Endpoint
- Median Percent Change in Triglycerides From Baseline to Final Visit
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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 in subjects with abnormal lipid (fat) levels in the blood.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
ABT-335 + atorvastatin + ezetimibe
Intervention: ABT-335
ABT-335 + atorvastatin + ezetimibe
Intervention: atorvastatin
ABT-335 + atorvastatin + ezetimibe
Intervention: ezetimibe
Placebo + atorvastatin + ezetimibe
Intervention: placebo
Placebo + atorvastatin + ezetimibe
Intervention: atorvastatin
Placebo + atorvastatin + ezetimibe
Intervention: ezetimibe
Outcomes
Primary Outcomes
Median Percent Change in Triglycerides From Baseline to Final Visit
Time Frame: 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
Time Frame: Baseline to 12 weeks (Final Visit)
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
Secondary Outcomes
- Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit(Baseline to 12 weeks (final visit))
- Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
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