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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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080220348
Enrollment
Unknown
Registered
2007-01-31
Start date
2007-01-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesteremia

Interventions

investigational material(s) Generic name etc : Rosuvastatin INN of investigational material : Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration for Investigational

Sponsors

AstraZeneca/Shionogi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 20 Years - 75 Years Genders Eligible for Study: Both Criteria 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety/Efficacy Primary Outcomes: Percentage change from baseline (before the start of rosuvastatin treatment) to Week 76 in the plaque volume (PV) Secondary Outcomes: 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, non HDL-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—

Contacts

Public Contact; ;

AstraZeneca;Shionogi & Co Ltd

;;

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026