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

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”

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.

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

Primary Measures

• Median Percent Change in Triglycerides From Baseline to Final Visit
  • Time Frame: Baseline to 12 Weeks (Final Visit)
    Safety Issue?: No
• Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (Final Visit)
    Safety Issue?: No

Secondary Measures

• Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (Final Visit)
    Safety Issue?: No
• Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (final visit)
    Safety Issue?: No
• Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (Final Visit)
    Safety Issue?: No
• 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)
    Safety Issue?: No
• Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (Final Visit)
    Safety Issue?: No
• Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit
  • Time Frame: Baseline to 12 weeks (Final Visit)
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abbott Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639158

Study ID Number: M10-275

ClinicalTrials.gov Identifier: NCT00639158

Health Authority: United States: Food and Drug Administration