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 - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00639158

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 III

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:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Procetofen Atorvastatin Atorvastatin calcium Ezetimibe Choline fenofibrate

U.S. FDA Resources

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

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):

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.

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
Fenofibric acid

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 February 12, 2012