Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy
NCT ID: NCT01726816
Last Updated: 2017-05-03
Study Results
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Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2012-10-31
2014-09-30
Brief Summary
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* Screening period (4 week)
* Double blind treatment period (16 weeks)
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Detailed Description
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2. Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probucol 250mg/day
Probucol 250mg group: probucol 250mg 2 tablets, 16 weeks
Probucol 250mg/day
Probucol 250mg + Placebo
Probucol 500mg/day
Probucol 500mg group: probucol 250mg 2 tablets, 16 weeks
Probucol 500mg/day
Probucol 500mg + Placebo
Placebo
Placebo group: placebo 2 tablets, 16 weeks
Placebo
Probucol matching placebo
Interventions
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Probucol 250mg/day
Probucol 250mg + Placebo
Probucol 500mg/day
Probucol 500mg + Placebo
Placebo
Probucol matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Urinary albumin excretion \> 300 mg/g Cr at screening visit
3. Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
4. Subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin)
5. 15 mL/min ≤ eGFR ≤ 90 mL min
6. Subjects must be willing and able to give signed and dated written informed consent.
Exclusion Criteria
2. Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
3. Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
4. Cardiac damage (abnormally levels of Troponin I)
5. Subject with medical history of cardiac syncope or primary syncope
6. Has condition that may prolong QTc interval (for man QTc interval\>450msec, for woman QTc interval\>470msec) at screening
7. Pregnant or lactating woman before randomization
8. Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
9. Cholestasis
10. Congestive heart failure
11. Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
12. Subjects has a diagnosis of NYHA grade III-IV status
13. AST or ALT is 3.0 times higher than the upper limit of the normal range
14. Active hepatitis Or Liver cirrhosis
15. Subjects with Hyperkalemia (K\>5.5 mEq/L)
16. Subjects with Renal Artery stenosis
17. Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
18. Urinary tract disease (urinary tract infection, Neurogenic bladder)
19. Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
20. Has an allergic history to probucol
21. HbA1c \> 9%
22. Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
23. Subjects taken probucol within 3 months prior to Screening
24. The subject has received an investigational product or biological agent within 3 months prior to screening
25. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
20 Years
80 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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MoonKyu Lee, professor
Role: STUDY_CHAIR
Samsung Medical Center
Locations
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The Catholic university of Korea, Bucheon St. Mary's Hospital
Bucheon-si, , South Korea
Kyungpook National University
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Gil Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk national University Hospital
Jeonju, , South Korea
Eulji Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Kangnam Sacred Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyunghee Univ Hospital at Kangdong
Seoul, , South Korea
Samsumg Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
SungNam, , South Korea
St. Vincent Hospital
Suwon, , South Korea
UIJEONGBU ST. MARY's HOSPITAL
Uijeongbu-si, , South Korea
Countries
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References
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Jin SM, Han KA, Yu JM, Sohn TS, Choi SH, Chung CH, Park IeB, Rhee EJ, Baik SH, Park TS, Lee IK, Ko SH, Hwang YC, Cha BS, Lee HW, Nam MS, Lee MK. Probucol in Albuminuric Type 2 Diabetes Mellitus Patients on Renin-Angiotensin System Blockade: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Arterioscler Thromb Vasc Biol. 2016 Oct;36(10):2108-14. doi: 10.1161/ATVBAHA.116.308034. Epub 2016 Aug 4.
Other Identifiers
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009-KOA-1201i
Identifier Type: -
Identifier Source: org_study_id
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