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OLE Study to Evaluate Safety / Efficacy of ZD4522

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654303
First received: April 2, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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:

MedlinePlus related topics: Cholesterol
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
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
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: 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