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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: ABT-335 + atorvastatin + ezetimibe
  • Placebo Comparator: Placebo + atorvastatin + ezetimibe

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
    • Time Frame: Baseline to 12 weeks (Final Visit)
    • [(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100
  • Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Apolipoprotein B (apoB) From Baseline to Final Visit
    • Time Frame: 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
    • Time Frame: Baseline to 12 weeks (Final Visit)
    • [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Maureen Kelly, MD, Abbott

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.