Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00812955

Purpose

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Condition	Intervention	Phase
Dyslipidemias Hypercholesterolemia Coronary Heart Disease Hypertriglyceridemia	Drug: ABT-143 Drug: simvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases Triglycerides

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Percent change in LDL-C with ABT-143 20/135 mg versus simvastatin 40 mg [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
LDL-C [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change in LDL-C, with ABT-143 (10/135 mg) versus simvastatin 40 mg [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent change in LDL-C with ABT-143 (5/135 mg) versus simvastatin 40 mg [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	474
Study Start Date:	November 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A ABT-143 capsules 5/135 mg	Drug: ABT-143 Once daily for 57 days Other Name: ABT-143
Experimental: B ABT-143 capsules 10/135 mg	Drug: ABT-143 Once daily for 57 days Other Name: ABT-143
Experimental: C ABT-143 capsules 20/135 mg	Drug: ABT-143 Once daily for 57 days Other Name: ABT-143
Active Comparator: D Simvastatin capsules 40 mg	Drug: simvastatin Once daily for 57 days simvastatin capsules 40 mg Other Name: simvastatin

Eligibility

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

Criteria

Inclusion Criteria:

Patients with hypercholesterolemia and hypertriglyceridemia.

Exclusion Criteria:

Patients with certain chronic or unstable medical conditions.
Patients receiving coumadin, cyclosporine, or certain other medications.
Pregnant or lactating women, or women intending to become pregnant.
Patient with diabetes mellitus that is poorly controlled.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812955

Show 114 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Maureen Kelly, MD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roth EM, McKenney JM, Kelly MT, Setze CM, Carlson DM, Gold A, Stolzenbach JC, Williams LA, Jones PH. Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: a randomized, double-blind study. Am J Cardiovasc Drugs. 2010;10(3):175-86.

Responsible Party:	Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00812955 History of Changes
Other Study ID Numbers:	M10-667
Study First Received:	December 18, 2008
Last Updated:	September 13, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Hypertriglyceridemia
Dyslipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias

Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012