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Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

NCT01043380 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2015-04-01

No results posted yet for this study

Summary

The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.

Conditions

Interventions

DRUG

Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]

Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.

DRUG

Lipitor (Atorvastatin) monotherapy

The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.

Sponsors & Collaborators

  • Kumamoto University

    lead OTHER

Principal Investigators

  • Hisao Ogawa, MD, PhD · Kumamoto University, Graduate School of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-03-31
Completion
2014-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043380 on ClinicalTrials.gov