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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00408382
Other study ID # A5481/HOP1
Secondary ID
Status Completed
Phase Phase 4
First received December 5, 2006
Last updated November 15, 2011

Study information

Verified date December 2006
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
atorvastatin, Lipitor


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Epub 2009 Feb 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in plaque characteristics as observed by coronary angioscopy
Primary (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
Primary Changes in the volume and the echogenicity as observed by intravascular ultrasound
Secondary Rate of change in serum lipid level
Secondary 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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