Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

Phase 3

Completed

• Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
• Interventions: Drug: ABT-335; Drug: Simvastatin; Drug: Placebo

• Registration Number: NCT00300456
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-09
• Primary Completion: 2007-03
• Results First Submitted: 2009-01-14
• Results First Submitted QC: 2009-02-20
• Results First Posted: 2009-03-25
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-29
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

Inclusion Criteria

• Subjects with mixed dyslipidemia
• Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

• Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
• Patients who are taking certain medications or unstable dose of specific 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
C	ABT-335	ABT-335 monotherapy
A	ABT-335	ABT-335 + 20 mg simvastatin
B	ABT-335	ABT-335 + 40 mg simvastatin
B	Simvastatin	ABT-335 + 40 mg simvastatin
C	Placebo	ABT-335 monotherapy
D	Simvastatin	20 mg simvastatin monotherapy
D	Placebo	20 mg simvastatin monotherapy
E	Simvastatin	40 mg simvastatin monotherapy
E	Placebo	40 mg simvastatin monotherapy
F	Simvastatin	80 mg simvastatin monotherapy
F	Placebo	80 mg simvastatin monotherapy
A	Simvastatin	ABT-335 + 20 mg simvastatin

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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 Total Cholesterol From Baseline to Final Visit	Baseline to 12 Weeks (Final Visit)	\[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol\] x 100
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit	Baseline to 12 Weeks (Final Visit)	\[(Week 12 Apo B minus baseline Apo B)/baseline Apo B\] 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

Trial Locations

Locations (1)

Global Medical Information; 🇺🇸 North Chicago, Illinois, United States