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

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

Purpose

The purpose of this study is to test the effects of using an investigational drug regimen containing two medications; once daily ABT-335 (Investigational drug) administered in combination with once daily simvastatin inpatients with abnormal lipid levels in the blood.

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

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Lipids

U.S. FDA Resources

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

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 ]
Identify rate of change by measuring baseline levels of Direct LDL-C at various study intervals) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Non-HDL-C, VLDL-C, Total Cholesterol, Lipoprotein apoB, hsCRP [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	560
Study Start Date:	March 2006
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 20 mg	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information
B: Active Comparator 40 mg	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Simvastatin daily, 12 weeks, see Arm Description for dosage information
C: Placebo Comparator Simvastatin Placebo	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Placebo Daily, 12 weeks, see Arm Description for placebo information
D: Placebo Comparator 20mg drug and ABT-335 Placebo	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 drug and ABT-335 Placebo	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 drug and ABT-335 Placebo	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.
Wome 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

Responsible Party:	Abbott ( Maureen Kelly, MD )
Study ID Numbers:	M05-749
Study First Received:	March 7, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00300456
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Abbott:

Dyslipidemia
Coronary Heart Disease
Mixed Dyslipidemia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Simvastatin
Myocardial Ischemia
Vascular Diseases
Ischemia

Arteriosclerosis
Coronary Disease
Metabolic disorder
Coronary Artery Disease
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 January 15, 2009