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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

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, comparing the following treatment groups in, ranked order: 1. ABT-143 (10/135 mg) versus simvastatin 40 mg 2. 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
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

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

More Information

No publications provided

Responsible Party:	Abbott ( Laura Williams, MD, MPH )
Study ID Numbers:	M10-667
Study First Received:	December 18, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00812955 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on November 20, 2009