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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00300456

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia	Drug: ABT-335 Drug: Simvastatin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Mean Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as 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) ] [ Designated as safety issue: No ]
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]
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 ]
Mean Percent Change in Total Cholesterol From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ]
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as 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) ] [ Designated as safety issue: No ]

Enrollment:	657
Study Start Date:	March 2006
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator ABT-335 + 20 mg simvastatin	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information
B: Active Comparator ABT-335 + 40 mg simvastatin	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information
C: Placebo Comparator ABT-335 monotherapy	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information
D: Placebo Comparator 20 mg simvastatin monotherapy	Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information
E: Placebo Comparator 40 mg simvastatin monotherapy	Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information
F: Placebo Comparator 80 mg simvastatin monotherapy	Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information

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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300456

Locations

United States, Illinois
Global Medical Information
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

More Information

Additional Information:

You can access information on these products by clicking on the product name. This link exits the ClinicalTrials.gov site

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Jones PH, Bays HE, Davidson MH, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme. Clin Drug Investig. 2008;28(10):625-34.

Responsible Party:	Abbott ( Maureen Kelly, MD )
Study ID Numbers:	M05-749
Study First Received:	March 7, 2006
Results First Received:	January 14, 2009
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00300456 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Abbott:

Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia

Additional relevant MeSH terms:

Antimetabolites
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Cardiovascular Diseases
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010