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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00639158
First received: March 14, 2008
Last updated: June 9, 2011
Last verified: June 2011

March 14, 2008
June 9, 2011
February 2008
October 2008   (final data collection date for primary outcome measure)
  • Median Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
  • Identify rate of change by measuring baseline levels of triglycerides at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Identify rate of change by measuring baseline levels of HDL-C at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00639158 on ClinicalTrials.gov Archive Site
  • Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(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) ] [ Designated as safety issue: No ]
    [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100
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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
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dyslipidemias
  • Coronary Heart Disease
  • Combined (Atherogenic) Dyslipidemia
  • Mixed Dyslipidemia
  • Drug: ABT-335
    135 mg capsule, daily, 12 weeks
    Other Names:
    • ABT-335
    • TriLipix
    • Fenofibric acid
    • Choline Fenofibrate
  • Drug: placebo
    placebo capsule, daily, 12 weeks
    Other Name: placebo
  • Drug: atorvastatin
    40 mg, tablet, daily, 12 weeks
    Other Names:
    • atorvastatin
    • Lipitor
  • Drug: ezetimibe
    10 mg capsule, daily, 12 weeks
    Other Names:
    • ezetimibe
    • Ezetrol
    • Zetia
    • Ezemibe
  • Active Comparator: ABT-335 + atorvastatin + ezetimibe
    Interventions:
    • Drug: ABT-335
    • Drug: atorvastatin
    • Drug: ezetimibe
  • Placebo Comparator: Placebo + atorvastatin + ezetimibe
    Interventions:
    • Drug: placebo
    • Drug: atorvastatin
    • Drug: ezetimibe
Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
543
Not Provided
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639158
M10-275
No
Maureen Kelly, MD, Abbott
Abbott
Not Provided
Not Provided
Abbott
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP