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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: December 5, 2006
Last updated: November 15, 2011
Last verified: December 2006
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

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: 50

Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00408382

Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Inc
  More Information

Publications: Identifier: NCT00408382     History of Changes
Other Study ID Numbers: A5481/HOP1
Study First Received: December 5, 2006
Last Updated: November 15, 2011

Keywords provided by Astellas Pharma Inc:
yellow coronary plaque

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 17, 2017