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CompletedNCT00408382Updated Nov 17, 2011

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

A Phase 4 interventional study of atorvastatin, Lipitor in Hypercholesteremia and Coronary Artery Disease, sponsored by Astellas Pharma Inc. Completed at 2 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2011-11-17.

Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
20 Years to 74 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hypercholesteremia
  • Coronary Artery Disease

Keywords

  • Lipitor
  • atorvastatin
  • Hypercholesteremia
  • yellow coronary plaque
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with hypercholesteremia
  • The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

Exclusion criteria

Exclusion Criteria:

  • Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
  • Acute cardiac infarction
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • Drugatorvastatin, Lipitor
06

What researchers measure

Primary outcomes

  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 outcomes

  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)

07

Study locations

2 sites
  • Osaka, Japan
  • Tokyo, Japan
08

References and documents

Publications

  • 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. PubMed 19225206 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00408382
Lead sponsor
Astellas Pharma Inc
First posted
Dec 6, 2006
Last update
Nov 17, 2011

Study contacts

Use Central Contact
study director · Astellas Pharma Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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