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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00654602 |
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
Condition | Intervention | Phase |
---|---|---|
Dyslipidaemia |
Drug: Rosuvastatin Behavioral: Maintenance of specific diet |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia. |
Estimated Enrollment: | 1500 |
Study Start Date: | February 2002 |
Study Completion Date: | February 2005 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 4522Il/0091, D3560C00091 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654602 |
Health Authority: | Australia: National Health and Medical Research Council; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; South Africa: Medicines Control Council |
cholesterol low density lipoproteins dyslipidaemia Rosuvastatin Crestor |
Lipid Metabolism, Inborn Errors Hypercholesterolemia, autosomal dominant Hyperlipidemias Metabolic Diseases Hyperlipoproteinemia Type II Metabolism, Inborn Errors Rosuvastatin |
Genetic Diseases, Inborn Metabolic disorder Hypercholesterolemia Dyslipidemias Hyperlipoproteinemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |