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Sponsors and Collaborators: |
AstraZeneca Shionogi |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00329160 |
The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).
Condition | Intervention | Phase |
---|---|---|
Hypercholesteremia |
Drug: Rosuvastatin Drug: HMG CoA inhibitor |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography |
Estimated Enrollment: | 200 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Research Site | |
Sapporo, Japan | |
Research Site | |
Shinjo, Japan | |
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Inba-mura, Japan | |
Research Site | |
Tokyo, Japan | |
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Yokohama, Japan | |
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Ichinomiya, Japan | |
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Komaki, Japan | |
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Gifu, Japan | |
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Kyoto, Japan | |
Research Site | |
Suita, Japan | |
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Osaka, Japan | |
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Izumisano, Japan | |
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Kobe, Japan | |
Research Site | |
Konan-cho, Japan | |
Research Site | |
Ube, Japan | |
Research Site | |
Shunan, Japan | |
Research Site | |
Kurume, Japan | |
Research Site | |
Kumamoto, Japan | |
Research Site | |
IZUMI, Japan | |
Research Site | |
Omiya, Japan | |
Research Site | |
Kanazawa, Japan | |
Research Site | |
Hamada, Japan | |
Research Site | |
Izumo, Japan | |
Research Site | |
Yamaguchi, Japan | |
Research Site | |
Kasuga, Japan | |
Research Site | |
Kagoshima, Japan | |
Research Site | |
Hiroshima, Japan |
Principal Investigator: | Masunori Matsuzaki, MD | Yamaguchi University Hospital |
Study ID Numbers: | D3565L00002, 0407E1841 |
Study First Received: | May 22, 2006 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00329160 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Coronary Disease Rosuvastatin Metabolic disorder Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |