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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00300482

Purpose

The primary 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 rosuvastatin calcium in patients with abnormal lipid levels in the blood.

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

MedlinePlus related topics: Calcium Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin Rosuvastatin calcium Calcium gluconate Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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:	1250
Study Start Date:	March 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 10mg	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information
B: Active Comparator 20 mg	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information
C: Placebo Comparator Rosuvastatin Placebo	Drug: ABT-335 135 mg, daily, 12 weeks Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type
D: Placebo Comparator 10 mg drug and ABT-335 Placebo	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type
E: Placebo Comparator 20mg drug and ABT-335 Placebo	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type
F: Placebo Comparator 40 mg drug and ABT-335 Placebo	Drug: Rosuvastatin Calcium Daily, 12 weeks, see Arm Description for dosage information Drug: Placebo Daily, 12 weeks, see Arm Description for information regarding placebo type

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:

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.
Women 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: NCT00300482

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:	M05-748
Study First Received:	March 7, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00300482
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
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis

Coronary Disease
Calcium, Dietary
Rosuvastatin
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