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Sponsors and Collaborators: |
University of Pennsylvania Aegerion Pharmaceuticals, Inc. |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00405067 |
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: BMS-201038 (AEGR-733) Drug: Ezetimibe |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Active Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination BMS-201038 (AEGR-733) and Ezetimibe vs. Monotherapy in Subjects With Moderate Hypercholesterolemia |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2007 |
Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8.
Approximately 60 subjects will be randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment.
Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Pharmanet, Inc | |
Princeton, New Jersey, United States, 08540-6242 |
Principal Investigator: | Michael Davidson, MD | Radiant Research |
Principal Investigator: | Jackson Downey, MD | Jacksonville Center for Clinical Research |
Principal Investigator: | Paul Grena, MD | Cardiology Consultants of Philadelphia |
Principal Investigator: | Barry Lubin, MD | Hampton Roads Center for Clinical Research |
Principal Investigator: | James McKenney, Pharm D | National Clinical Research |
Principal Investigator: | Eli Roth, MD | Sterling Research Group, LTD |
Study ID Numbers: | AEGR-733-001 |
Study First Received: | November 28, 2006 |
Last Updated: | November 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00405067 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cholesterol |
Antimetabolites Metabolic Diseases Hyperlipidemias Antilipemic Agents Ezetimibe |
Anticholesteremic Agents Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Metabolic Diseases Hyperlipidemias Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Ezetimibe Anticholesteremic Agents Hypercholesterolemia Pharmacologic Actions Dyslipidemias Lipid Metabolism Disorders |