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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408382
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : November 17, 2011
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesteremia Coronary Artery Disease Drug: atorvastatin, Lipitor Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Primary Outcome Measures :
  1. Changes in plaque characteristics as observed by coronary angioscopy
  2. (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
  3. Changes in the volume and the echogenicity as observed by intravascular ultrasound

Secondary Outcome Measures :
  1. Rate of change in serum lipid level
  2. Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408382

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

Publications: Identifier: NCT00408382     History of Changes
Other Study ID Numbers: A5481/HOP1
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: December 2006

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