The purpose of this study is to assess the long term safety of Crestor.
..Date First Received: April 2, 2008
Last Updated: April 2, 2008
Verified by: AstraZeneca, April 2008
Clinical Trial Phase: Phase 3 | Start Date: August 1999
Overall Status: Completed
Estimated Enrollment: 3500
Brief Summary
Official Title: “ZD4522 Long Term Extension Trial”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to assess the long term safety of Crestor.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: February 2005
Intervention(s) in this Clinical Trial
- Drug: Rosuvastatin
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Rosuvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Safety, as determined by adverse events, laboratory data, physical examination and ECG.
- Time Frame: 12 weekly
- Time Frame: 12 weekly
Secondary Measures
- Success in achieving goals for Cholesterol levels
- Time Frame: 12 weekly
- Time Frame: 12 weekly
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Elinor Miller, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654303
Study ID Number: 4522IL/0034
ClinicalTrials.gov Identifier: NCT00654303
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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