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Sponsors and Collaborators: |
Abbott AstraZeneca |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00463606 |
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
Condition | Intervention | Phase |
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Hypercholesterolemia Dyslipidemia |
Other: ABT-335 and Rosuvastatin Combination Drug: ABT-335 Drug: rosuvastatin calcium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia |
Enrollment: | 760 |
Study Start Date: | April 2007 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ABT-335 and Rosuvastatin Calcium: Active Comparator
ABT-335 135mg in combination with rosuvastatin calcium 5mg QD
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Other: ABT-335 and Rosuvastatin Combination
12 Weeks, see Arm for intervention description
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ABT-335: Placebo Comparator
ABT-335 135mg monotherapy QD
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Drug: ABT-335
12 Weeks, see Arm for intervention description
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Rosuvastatin Calcium: Placebo Comparator
Rosuvastatin calcium 5mg monotherapy QD
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Drug: rosuvastatin calcium
12 Weeks, see Arm for intervention description
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Dawn Carlson, MD, MPH, FCCP ) |
Study ID Numbers: | M06-844 |
Study First Received: | April 19, 2007 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00463606 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Rosuvastatin Metabolic Diseases Hyperlipidemias Fenofibric acid |
Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |