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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639158
• Other study ID #: M10-275
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2008
• Last updated: June 9, 2011
• Start date: February 2008

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Combined (Atherogenic) Dyslipidemia
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dyslipidemias
• Mixed Dyslipidemia
• Myocardial Ischemia

Intervention

Drug:
• ABT-335
135 mg capsule, daily, 12 weeks
• placebo
placebo capsule, daily, 12 weeks
• atorvastatin
40 mg, tablet, daily, 12 weeks
• ezetimibe
10 mg capsule, daily, 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Percent Change in Triglycerides From Baseline to Final Visit	[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100	Baseline to 12 Weeks (Final Visit)	No
Primary	Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit	[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100	Baseline to 12 weeks (Final Visit)	No
Secondary	Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit	[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100	Baseline to 12 weeks (Final Visit)	No
Secondary	Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit	[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100	Baseline to 12 weeks (final visit)	No
Secondary	Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit	[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100	Baseline to 12 weeks (Final Visit)	No
Secondary	Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit	[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100	Baseline to 12 weeks (Final Visit)	No
Secondary	Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit	[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100	Baseline to 12 weeks (Final Visit)	No
Secondary	Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit	[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100	Baseline to 12 weeks (Final Visit)	No