At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 214 enrolled
Drug / intervention
Rosuvastatin +1 moredrug
Likely dose
Rosuvastatin 2.5-20 mgAI-extracted
Key inclusion· 4
- ✓Age 20 to 75 years
- ✓Plan to undergo coronary angiography or percutaneous coronary intervention
- ✓LDL cholesterol ≥140 mg/dL in untreated patients
- ✓LDL cholesterol ≥100 mg/dL in patients already on lipid-lowering therapy
Key exclusion· 5
- ✕Acute myocardial infarction within 72 hours of onset
- ✕Heart failure NYHA Class III or higher
- ✕Serious arrhythmia
- ✕Currently receiving LDL-apheresis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Rosuvastatin and HMG CoA inhibitor for Hypercholesteremia. Completed, enrolled 214 participants across 27 sites.
Detailed 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 intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesteremia
CountriesJapan
CollaboratorsShionogi
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedMay 2006
Primary CompletionOct 2008
TodayJul 2026
First PostedMay 24, 2006
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.1 years ago
Interventions
Rosuvastatindrug
2.5-20 mg
HMG CoA inhibitordrug
3-hydroxy-3-methylglutaryl-coenzyme A