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Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease

NCT01291641 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2019-09-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean IMT) at year 1, 2, and 3.

Conditions

  • Hyperlipidemias

Interventions

DRUG

HMG-CoA Reductase Inhibitor

During the study period, HMGCoA reductase inhibitor is continuously administered to the patients. Dosage regimen: following the package insert of each HMGCoA reductase inhibitor

DRUG

Probucol

In addition to the continued HMGCoA reductase inhibitor treatment, probucol is administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner)

DRUG

Cilostazol

In addition to the continued HMGCoA reductase inhibitor treatment, probucol and cilostazol are administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) Cilostazol 100-mg tablet, twice daily by the oral route

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Byung-Hee Oh, M.D. · Seoul National University Hospital

  • Cheol Ho Kim, M.D. · Seoul National University Bundang Hospital

  • Sang-Hyun Kim, M.D. · SMG-SNU Boramae Medical Center

  • Moo-Hyun Kim, M.D. · Dong-A medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • South Korea

Study Locations

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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 NCT01291641 on ClinicalTrials.gov