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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00240318 |
The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries
Condition | Intervention | Phase |
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Coronary Arteriosclerosis |
Drug: Rosuvastatin calcium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A 104-Week, Open-Label, Multi-Centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease |
Estimated Enrollment: | 450 |
Study Start Date: | November 2002 |
Study Completion Date: | November 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2. Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study.
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Study Director: | AstraZeneca Crestor Medical Sciences Director, MD | AstraZeneca |
Study ID Numbers: | D3562C00076 |
Study First Received: | October 16, 2005 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00240318 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Coronary Artery Disease |
Antimetabolites Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Antilipemic Agents Vascular Diseases Arteriosclerosis |
Ischemia Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Calcium, Dietary Rosuvastatin Coronary Artery Disease |
Arterial Occlusive Diseases Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors Arteriosclerosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Rosuvastatin Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |