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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00185107 |
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia |
Drug: Colesevelam Hydrochloride Drug: Ezetimibe Drug: Simvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia |
Estimated Enrollment: | 45 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | October 2005 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Scripps Clinic | |
San Diego, California, United States, 92128 | |
United States, Florida | |
Renstar Medical Research | |
Ocala, Florida, United States, 34471 | |
United States, Kansas | |
Radiant Research | |
Overland Park, Kansas, United States, 66215 | |
United States, Kentucky | |
L-MARC Research Center | |
Louisville, Kentucky, United States, 40213 | |
United States, Minnesota | |
Radiant Research | |
Edina, Minnesota, United States, 55435 | |
United States, North Carolina | |
Medical Office | |
Statesville, North Carolina, United States, 28677 | |
United States, Ohio | |
Linder Clinical Trial Center | |
Cincinnati, Ohio, United States, 45219 |
Study ID Numbers: | WEL-408 |
Study First Received: | September 9, 2005 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00185107 |
Health Authority: | United States: Food and Drug Administration |
Safety Efficacy WelChol® Zocor® Zetia® |
Colesevelam Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe |
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 |