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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014