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Clinical Trials/NCT00408382
NCT00408382CompletedPhase 4

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

Astellas Pharma Inc2 sites in 1 country50 target enrollmentStarted: December 6, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Changes in plaque characteristics as observed by coronary angioscopy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 74 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Study Sites (2)

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