Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease
NCT ID: NCT01291641
Last Updated: 2019-09-20
Study Results
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Basic Information
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COMPLETED
PHASE4
342 participants
INTERVENTIONAL
2011-03-31
2017-03-31
Brief Summary
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To Compare the Effect of Concomitant Administration of Probucol and Cilostazol With Probucol Single Treatment on the Atherosclerosis Related Markers (Including the Thickness of the Achilles Tendon) and Evaluate Safety (Based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject
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Detailed Description
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Group A : HMGCoA reductase inhibitor continued
Group B : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
Group C : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID +Cilostazol 100 mg PO, BID
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
HMGCoA reductase inhibitor continued
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
Group B
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
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)
Group C
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID
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
Interventions
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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
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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\) Subjects with coronary heart disease longer than 3 months.
* 3\) Subjects being treated with HMGCoA reductase inhibitors(Statins)
* 4\) Subjects with an max IMT equal to or greater than 1.2 mm
* 5\) Subjects with an LDL-Cholesterol less than 200mg/dl
* 6\) Subjects whose voluntary written informed consent is obtained for participation in this study
Exclusion Criteria
* 2\) Subjects who took cilostazol within 3 months before participation of the study
* 3\) Subjects with a history of hypersensitivity to probucol or cilostazol
* 4\) Subjects with homozygous familial hyperlipidemia\*
* 5\) Subjects with a triglyceride ( TG) level greater than 400mg/dL at screening
* 6\) Subjects with uncontrolled diabetes : HbA1c level greater than 9%
* 7\) Subjects with New York Heart Association (NYHA) classification: Class Ⅲ and Ⅳ
* 8\) Subjects with a QTc interval greater than 450msec(male) 470msec(female)
* 9\) Subjects with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole)
* 10\) Subjects with atrial fibrillation (including paroxysmal AF)
* 11\) Subjects with unstable angina
* 12\) Subjects with liver and kidney functions that satisfy the following criteria - AST or ALT \>100 IU/L, serum creatinine \>1.5 mg/dL
* 13\) Subjects who are participating in another clinical trial
* 14\) Subjects with pregnant or possibly pregnant without appropriate contraception control. Appropriate contraception control means that Oral contraception for greater than 4 weeks, surgical contraception including loop insertion, condom use etc. Women who has no possibility of pregnancy because of surgery or menopause should not be regarded the subject with possibly pregnant
* 15\) Subjects with clinically significant disorders of blood coagulation
* 16\) Subjects who are not considered by the physicians to be appropriate to participate in this trial for any other reason
20 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Byung-Hee Oh
Professor of Internal Medicine/Cardiology
Principal Investigators
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Byung-Hee Oh, M.D.
Role: STUDY_CHAIR
Seoul National University Hospital
Cheol Ho Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Sang-Hyun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Moo-Hyun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dong-A medical center
Locations
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Dong-A Medical Center
Seogu, Busan, South Korea
Samsung Medical Center
Seoul, Gangnam-Gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Countries
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References
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Other Identifiers
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IMT-01
Identifier Type: -
Identifier Source: org_study_id
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