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
  Purpose

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.


Condition Intervention Phase
Dyslipidemias
Coronary Heart Disease
Combined (Atherogenic) Dyslipidemia
Mixed Dyslipidemia
Drug: ABT-335
Drug: placebo
Drug: atorvastatin
Drug: ezetimibe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 543
Study Start Date: February 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABT-335 + atorvastatin + ezetimibe Drug: ABT-335
135 mg capsule, daily, 12 weeks
Other Names:
  • ABT-335
  • TriLipix
  • Fenofibric acid
  • Choline Fenofibrate
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
Placebo Comparator: Placebo + atorvastatin + ezetimibe 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639158

  Show 119 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00639158     History of Changes
Other Study ID Numbers: M10-275
Study First Received: March 14, 2008
Results First Received: October 2, 2009
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Dyslipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014