Safety and Efficacy Study Comparing ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Abnormal Lipid (Fat) Levels in the Blood - Full Text View

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

Purpose

The primary purpose of this study is to test the effect and safety of using an investigational drug regimen containing three medications; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin and once daily ezetimibe to study the effects on patients 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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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: Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Identify rate of change by measuring baseline levels of triglycerides at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Identify rate of change by measuring baseline levels of HDL-C at various study intervals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	543
Study Start Date:	February 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental ABT-335, atorvastatin, ezetimibe	Drug: ABT-335 135 mg capsule, daily, 12 weeks Drug: atorvastatin 40 mg, tablet, daily, 12 weeks Drug: ezetimibe 10 mg capsule, daily, 12 weeks
B: Placebo Comparator placebo, atorvastatin, ezetimibe	Drug: placebo placebo capsule, daily, 12 weeks Drug: atorvastatin 40 mg, tablet, daily, 12 weeks Drug: ezetimibe 10 mg capsule, daily, 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Patients with mixed dyslipidemia.

Exclusion Criteria:

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

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

Responsible Party:	Abbott ( Maureen Kelly, MD )
Study ID Numbers:	M10-275
Study First Received:	March 14, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00639158 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases
Ezetimibe
Anticholesteremic Agents

Ischemia
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Metabolic Disorder
Coronary Artery Disease
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on July 06, 2009