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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00654303 |
Purpose
The purpose of this study is to assess the long term safety of Crestor.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolaemia |
Drug: Rosuvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | ZD4522 Long Term Extension Trial |
| Estimated Enrollment: | 3500 |
| Study Start Date: | August 1999 |
| Study Completion Date: | February 2005 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Rosuvastatin
|
Drug: Rosuvastatin |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | AstraZeneca ( Elisabeth Björk ) |
| Study ID Numbers: | 4522IL/0034, D3560C00034 |
| Study First Received: | April 2, 2008 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00654303 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Ireland: Ministry of Health; Israel: Ministry of Health; Italy: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Sweden: The National Board of Health and Welfare; United Kingdom: Medicines and Healthcare Products Regulatory Agency; South Africa: Medicines Control Council |
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Cholesterol Hypercholesterolaemia Statins |
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Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Rosuvastatin Therapeutic Uses Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |