CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 342 enrolled
Drug / intervention
HMG-CoA Reductase Inhibitor +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01291641
NCT01291641Phase 4Completed
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Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy: A Randomized, Multicenter, Multinational Study

Seoul National University Hospital·interventional·Posted Feb 8, 2011·Updated Sep 20, 2019

In Brief

A Phase 4 clinical trial evaluating HMG-CoA Reductase Inhibitor, Probucol, and 1 other intervention for Hyperlipidemias. Completed, enrolled 342 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemias
CountriesSouth Korea
CollaboratorsKorea Otsuka Pharmaceutical Co., Ltd.

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2011
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.4 years ago

Interventions

HMG-CoA Reductase Inhibitordrug

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

Probucoldrug

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)

Cilostazoldrug

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