Back to resultsLipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
Primary Purpose
Hypercholesteremia, Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
atorvastatin, Lipitor
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesteremia focused on measuring Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque
Eligibility 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
Sites / Locations
Outcomes
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)
Full Information
NCT ID
NCT00408382
First Posted
December 5, 2006
Last Updated
November 15, 2011
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00408382
Brief Title
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia, Coronary Artery Disease
Keywords
Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atorvastatin, Lipitor
Primary Outcome Measure Information:
Title
Changes in plaque characteristics as observed by coronary angioscopy
Title
(the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Title
Changes in the volume and the echogenicity as observed by intravascular ultrasound
Secondary Outcome Measure Information:
Title
Rate of change in serum lipid level
Title
Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Osaka
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19225206
Citation
Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. doi: 10.1253/circj.cj-08-0755. Epub 2009 Feb 18.
Results Reference
background
Learn more about this trial
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
We'll reach out to this number within 24 hrs