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Completed

NCT Number: NCT00300456

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

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.

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Key information

Conditions

Dyslipidemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias 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

Global Medical Information

North Chicago, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ABT-335

Drug

135 mg, daily, 12 weeks

simvastatin

Drug

daily, 12 weeks, see Arm Description for dosage information

Placebo

Drug

Daily, 12 weeks, see Arm Description for placebo information

Primary outcomes

  1. Mean 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

  3. Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit

    Time frame: Baseline to 12 Weeks (Final Visit)

    [(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

Secondary outcomes

  1. 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

  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 Total Cholesterol From Baseline to Final Visit

    Time frame: Baseline to 12 Weeks (Final Visit)

    [(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100

  4. Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit

    Time frame: Baseline to 12 Weeks (Final Visit)

    [(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100

  5. 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 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

Important dates

Study start
2006
Primary completion
2007
First posted
Mar 9, 2006
Registry last updated
Jun 3, 2009

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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