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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00654446 |
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia
Condition | Intervention | Phase |
---|---|---|
Fredrickson Type IIa & Type IIb Dyslipidaemia |
Drug: Rosuvastatin Drug: Simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia |
Estimated Enrollment: | 442 |
Study Start Date: | September 2002 |
Study Completion Date: | July 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Rosuvastatin
|
Drug: Rosuvastatin |
2: Active Comparator
Simvastatin
|
Drug: Simvastatin |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Michael Cressman - Medical Science Director ) |
Study ID Numbers: | 4522IL/0099 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654446 |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; South Africa: Medicines Control Council |
Cholesterol low density lipoproteins dyslipidaemia Rosuvastatin Crestor |
Simvastatin Zocor Renal kidney |
Lipid Metabolism, Inborn Errors Hypercholesterolemia, autosomal dominant Hyperlipidemias Metabolic Diseases Simvastatin 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 |