Back to resultsOLE Study to Evaluate Safety / Efficacy of ZD4522
Primary Purpose
Hypercholesterolaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolaemia focused on measuring Cholesterol, Hypercholesterolaemia, Statins
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Rosuvastatin
Outcomes
Primary Outcome Measures
Safety, as determined by adverse events, laboratory data, physical examination and ECG.
Secondary Outcome Measures
Success in achieving goals for Cholesterol levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654303
Brief Title
OLE Study to Evaluate Safety / Efficacy of ZD4522
Official Title
ZD4522 Long Term Extension Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the long term safety of Crestor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia
Keywords
Cholesterol, Hypercholesterolaemia, Statins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Primary Outcome Measure Information:
Title
Safety, as determined by adverse events, laboratory data, physical examination and ECG.
Time Frame
12 weekly
Secondary Outcome Measure Information:
Title
Success in achieving goals for Cholesterol levels
Time Frame
12 weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elinor Miller, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
OLE Study to Evaluate Safety / Efficacy of ZD4522
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