Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

This study has been completed.

First Received: December 5, 2006 No Changes Posted

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00408382

Purpose

To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease

Condition	Intervention	Phase
Hypercholesteremia Coronary Artery Disease	Drug: atorvastatin, Lipitor	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Changes in plaque characteristics as observed by coronary angioscopy
(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Changes in the volume and the echogenicity as observed by intravascular ultrasound

Secondary Outcome Measures:

Rate of change in serum lipid level
Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with hypercholesteremia
The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

Exclusion Criteria:

Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
Acute cardiac infarction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408382

Locations

Japan

Osaka, Japan

Tokyo, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Inc

More Information

No publications provided

Study ID Numbers:	A5481/HOP1
Study First Received:	December 5, 2006
Last Updated:	December 5, 2006
ClinicalTrials.gov Identifier:	NCT00408382 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Lipitor
atorvastatin
Hypercholesteremia
yellow coronary plaque

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
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Atorvastatin
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010