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Completed

NCT Number: NCT00639158

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

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.

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Key information

Conditions

Dyslipidemias Cardiovascular Diseases Combined (Atherogenic) Dyslipidemia Coronary Disease Coronary Heart Disease Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-335

Drug

135 mg capsule, daily, 12 weeks

Other names: TriLipix, Fenofibric acid, Choline Fenofibrate

Placebo

Drug

placebo capsule, daily, 12 weeks

atorvastatin

Drug

40 mg, tablet, daily, 12 weeks

Other names: Lipitor

ezetimibe

Drug

10 mg capsule, daily, 12 weeks

Other names: Ezetrol, Zetia, Ezemibe

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
First posted
Mar 20, 2008
Registry last updated
Jun 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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