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OLE Study to Evaluate Safety / Efficacy of ZD4522
This study has been completed.
First Received: April 2, 2008   Last Updated: March 13, 2009   History of Changes
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Rosuvastatin calcium Rosuvastatin
U.S. FDA Resources

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
1: Experimental
Rosuvastatin
Drug: Rosuvastatin

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654303

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Elinor Miller, MD AstraZeneca
  More Information

No publications provided

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

Keywords provided by AstraZeneca:
Cholesterol
Hypercholesterolaemia
Statins

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010



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