May 22, 2006 |
December 12, 2007 |
October 2005 |
Percentage change from baseline (before the start of rosuvastatin treatment) to Week 76 in the plaque volume (PV) |
Same as current |
Complete list of historical versions of study NCT00329160 on ClinicalTrials.gov Archive Site |
- Change from baseline to Week 76 in PV in the target lesion
- Percentage changes from baseline to specified measurement time points in TC, LDL-C, VLDL-C, HDL-C, nonHDL-C, TG and RLP-C
- Changes in hs-CRP from baseline to specified measurement time points
- Safety; Adverse events, subjective symptoms/objective findings, physical tests), blood tests (hematology, clinical chemistry, glucose metabolism test),
urinalysis
|
- Change from baseline to Week 76 in PV in the target lesion
- Percentage changes from baseline to specified measurement time points in TC, LDL-C, VLDL-C, HDL-C, nonHDL-C, TG and RLP-C
- Changes in hs-CRP from baseline to specified measurement time points
- Safety; Adverse events, subjective symptoms/objective findings, physical tests), blood tests (hematology, clinical chemistry, glucose metabolism
test), urinalysis
|
|
Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease |
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography |
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 intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD). |
|
Phase IV |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Hypercholesteremia |
- Drug: Rosuvastatin
- Drug: HMG CoA inhibitor
|
|
|
|
Active, not recruiting |
200 |
October 2008 |
|
Inclusion Criteria:
- Signed written informed consent,
- 20 to 75 years old,
- Plan to undergo coronary angiography (CAG) or PCI and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)
Exclusion Criteria:
- Acute myocardial infarction within 72 hours after the onset,
- Heart failure of NYHA Class III or above,
- Serious arrhythmia,
- Being treated with LDL-apheresis
- History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
|
Both |
20 Years to 75 Years |
No |
|
Japan |
|
|
NCT00329160 |
|
0407E1841 |
AstraZeneca |
Shionogi |
Principal Investigator: |
Masunori Matsuzaki, MD |
Yamaguchi University Hospital |
|
|
AstraZeneca |
December 2007 |