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

This study is ongoing, but not recruiting participants.

First Received: May 22, 2006 Last Updated: December 12, 2007 History of Changes

Sponsor:	AstraZeneca
Collaborator:	Shionogi
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00329160

Purpose

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).

Condition	Intervention	Phase
Hypercholesteremia	Drug: Rosuvastatin Drug: HMG CoA inhibitor	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Ultrasound

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

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

Estimated Enrollment:	200
Study Start Date:	October 2005
Estimated Study Completion Date:	October 2008

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329160

Locations

Japan
Research Site
Sapporo, Japan
Research Site
Shinjo, Japan
Research Site
Inba-mura, Japan
Research Site
Tokyo, Japan
Research Site
Yokohama, Japan
Research Site
Ichinomiya, Japan
Research Site
Komaki, Japan
Research Site
Gifu, Japan
Research Site
Kyoto, Japan
Research Site
Suita, Japan
Research Site
Osaka, Japan
Research Site
Izumisano, Japan
Research Site
Kobe, Japan
Research Site
Konan-cho, Japan
Research Site
Ube, Japan
Research Site
Shunan, Japan
Research Site
Kurume, Japan
Research Site
Kumamoto, Japan
Research Site
IZUMI, Japan
Research Site
Omiya, Japan
Research Site
Kanazawa, Japan
Research Site
Hamada, Japan
Research Site
Izumo, Japan
Research Site
Yamaguchi, Japan
Research Site
Kasuga, Japan
Research Site
Kagoshima, Japan
Research Site
Hiroshima, Japan

Sponsors and Collaborators

AstraZeneca

Shionogi

Investigators

Principal Investigator:

Masunori Matsuzaki, MD

Yamaguchi University Hospital

More Information

No publications provided

Study ID Numbers:	D3565L00002, 0407E1841
Study First Received:	May 22, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00329160 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Antimetabolites
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Rosuvastatin
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010