OLE Study to Evaluate Safety / Efficacy of ZD4522
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654303
First received: April 2, 2008
Last updated: March 13, 2009
Last verified: March 2009
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Purpose
The purpose of this study is to assess the long term safety of Crestor.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolaemia |
Drug: Rosuvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ZD4522 Long Term Extension Trial |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Safety, as determined by adverse events, laboratory data, physical examination and ECG. [ Time Frame: 12 weekly ]
Secondary Outcome Measures:
- Success in achieving goals for Cholesterol levels [ Time Frame: 12 weekly ]
| Estimated Enrollment: | 3500 |
| Study Start Date: | August 1999 |
| Study Completion Date: | February 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Rosuvastatin
|
Drug: Rosuvastatin
Other Name: Crestor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of previous Crestor study as listed in the protocol.
Exclusion Criteria:
- Pregnant or breast feeding women, or not using appropriate contraception.
- Abnormal lab values as listed in the protocol.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Elisabeth Björk, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00654303 History of Changes |
| Other Study ID Numbers: | 4522IL/0034, D3560C00034 |
| Study First Received: | April 2, 2008 |
| Last Updated: | March 13, 2009 |
| 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 |
Keywords provided by AstraZeneca:
|
Cholesterol Hypercholesterolaemia Statins |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013