Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. in Subjects With Mixed Dyslipidemia. - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00300430

Purpose

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Condition	Intervention	Phase
Dyslipidemia Coronary Heart Disease Mixed Dyslipidemia	Drug: ABT-335 and rosuvastatin calcium Drug: ABT-335 and atorvastatin calcium Drug: ABT-335 and simvastatin	Phase III

MedlinePlus related topics: Calcium Coronary Artery Disease Heart Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Calcium gluconate Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Abbott:

Primary Outcome Measures:

Identify clinical and laboratory adverse events for each treatment group. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Laboratory parameters-changes from Baseline to each visit will be summarized for each treatment group with the mean, standard deviation and range. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Vital signs- changes from Baseline to each visit will be summarized for each treatment group with the mean, standard deviation and range. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identify rate of change by measuring baseline levels of triglycerides, HDL-C, Direct LDL-C, Non-HDL-C, VLDL-C, total cholesterol, Lipoprotein apoB, hsCRP. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	2370
Study Start Date:	September 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 20 mg drug and ABT-335	Drug: ABT-335 and rosuvastatin calcium ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
B: Active Comparator 40 mg drug and ABT 335	Drug: ABT-335 and atorvastatin calcium ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
C: Active Comparator 40 mg drug and ABT-335	Drug: ABT-335 and simvastatin ABT-335 135 mg plus simvastatin daily, 52 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Adult male and female subjects who voluntarily sign the informed consent.
Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion Criteria:

Subject is using or will use investigational medications, except as approved by Abbott.
Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300430

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:	M05-758
Study First Received:	March 7, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00300430
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

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

Coronary Disease
Calcium, Dietary
Rosuvastatin
Metabolic disorder
Coronary Artery Disease
Dyslipidemias
Atorvastatin
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