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

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

MedlinePlus related topics:

Heart Diseases

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Ezetimibe Lipids

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	460
Study Start Date:	March 2008
Estimated 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

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

Contacts


Contact: Debra M. Schuerr, BS	847-937-5748	debra.m.schuerr@abbott.com

Show 108 Study Locations

Sponsors and Collaborators

Abbott

More Information

Responsible Party:	Abbott ( Maureen Kelly, MD )
Study ID Numbers:	M10-275
First Received:	March 14, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00639158
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Coronary Disease

Metabolic Diseases

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ezetimibe

Ischemia

Metabolic disorder

Atorvastatin

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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