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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00653445 |
The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia Coronary Heart Disease Atherosclerosis |
Drug: Rosuvastatin Drug: Ezetimibe |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%). |
Study Start Date: | June 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Rosuvastatin 40mg/Ezetimibe 10mg combination therapy
|
Drug: Rosuvastatin
40mg
Drug: Ezetimibe
10mg
|
2: Experimental
Rosuvastatin 40 mg
|
Drug: Rosuvastatin
40mg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Elisabeth Björk ) |
Study ID Numbers: | D3569C00006 |
Study First Received: | April 2, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00653445 |
Health Authority: | United States: Food and Drug Administration; Switzerland: Swissmedic; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Department of Health |
Low density lipoproteins Hypercholesterolemia Coronary Heart Disease |
Rosuvastatin Crestor Ezetimibe |
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Myocardial Ischemia Vascular Diseases Ezetimibe Arteriosclerosis |
Ischemia 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 |