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

Phase 3

Completed

• Conditions: Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia; Dyslipidemias
• Interventions: Drug: ABT-335; Drug: placebo; Drug: atorvastatin; Drug: ezetimibe

• Registration Number: NCT00639158
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-20
• Primary Completion: 2008-10
• Results First Submitted: 2009-10-02
• Results First Submitted QC: 2009-10-02
• Results First Posted: 2009-11-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 543

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-335 + atorvastatin + ezetimibe	ABT-335	-
Placebo + atorvastatin + ezetimibe	placebo	-
ABT-335 + atorvastatin + ezetimibe	ezetimibe	-
ABT-335 + atorvastatin + ezetimibe	atorvastatin	-
Placebo + atorvastatin + ezetimibe	atorvastatin	-
Placebo + atorvastatin + ezetimibe	ezetimibe	-

Primary Outcome Measures

Name	Time	Method
Median 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

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit	Baseline to 12 weeks (Final Visit)	\[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\] x 100
Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit	Baseline to 12 weeks (Final Visit)	\[(Week 12 apoB minus baseline apoB)/baseline apoB\] x 100
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit	Baseline to 12 weeks (Final Visit)	\[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP\] x 100
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit	Baseline to 12 weeks (final visit)	\[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] x 100
Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit	Baseline to 12 weeks (Final Visit)	\[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\] x 100
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit	Baseline to 12 weeks (Final Visit)	\[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\] x 100