Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 22, 2006

Last Updated Date

December 12, 2007

Start Date ^†

October 2005

Current Primary Outcome Measures ^†

Percentage change from baseline (before the start of rosuvastatin treatment) to Week 76 in the plaque volume (PV)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00329160 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

Official Title ^†

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

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 intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hypercholesteremia

Intervention ^†

Drug: Rosuvastatin
Drug: HMG CoA inhibitor

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

200

Estimated Completion Date

October 2008

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00329160

Responsible Party

Secondary IDs ^††

0407E1841

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Shionogi

Investigators ^†

Principal Investigator:

Masunori Matsuzaki, MD

Yamaguchi University Hospital

Information Provided By

AstraZeneca

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.