Status:
COMPLETED
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Shionogi
Conditions:
Hypercholesteremia
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by int...
Eligibility Criteria
Inclusion
- Signed written informed consent,
- 20 to 75 years old,
- Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)
Exclusion
- Acute myocardial infarction within 72 hours after the onset,
- Heart failure of New York Heart Association (NYHA) Class III or above,
- Serious arrhythmia,
- Being treated with LDL-apheresis
- History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00329160
Start Date
October 1 2005
End Date
October 1 2008
Last Update
August 31 2011
Active Locations (27)
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1
Research Site
Gifu, Japan
2
Research Site
Hamada, Japan
3
Research Site
Hiroshima, Japan
4
Research Site
Ichinomiya, Japan