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OLE Study to Evaluate Safety / Efficacy of ZD4522

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654303
First Posted: April 7, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654303


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

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654303     History of Changes
Other Study ID Numbers: 4522IL/0034
D3560C00034
First Submitted: April 2, 2008
First Posted: April 7, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Cholesterol
Hypercholesterolaemia
Statins

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors