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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00408382
Enrollment
50
Registered
2006-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Hypercholesteremia

Keywords

Lipitor, atorvastatin, Hypercholesteremia, yellow coronary plaque

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

Interventions

DRUGatorvastatin, Lipitor

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 74 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026