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Clinical Trial Details

Trial ID: L4213
Source ID: NCT01726816
Associated Drug: Probucol 250mg/Day
Title: Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Nephropathy
Interventions: DRUG: Probucol 250mg/day|DRUG: Probucol 500mg/day|DRUG: Placebo
Outcome Measures: Primary: A/C ratio, The change in the A/C ratio from baseline to the end of treatment(16 week) \[Time Frame: baseline to 16 weeks\], 16 week | Secondary: Serum creatinine, The change in the Serum creatinine from baseline to the end of treatment., 16 week|eGFR, The change in the eGFR from baseline to the end of treatment(16 week), 16 week|cystatin C, The change in the cystatin C from baseline to the end of treatment(16 week), 16 week|urine albumin, The change in the urine albumin from baseline to the end of treatment(16 week), 16 week|P/C ratio, The change in the P/C ratio from baseline to the end of treatment(16 week), 16 week | Other: Total Cholesterol, The change in the Total cholesterol from baseline to the end of treatment(16 week), 16 week|Triglyceride, The change in the Triglyceride from baseline to the end of treatment(16 week), 16 week|LDL-C, The change in the LDL-C from baseline to the end of treatment(16 week), 16 week|HDL-C, The change in the HDL-C from baseline to the end of treatment(16 week), 16 week|oxidized LDL, The change in the oxidized LDL from baseline to the end of treatment(16 week), 16 week|d-ROM, The change in the d-ROM from baseline to the end of treatment(16 week), 16 week|urinary fibronectin, The change in the urinary fibronectin from baseline to the end of treatment(16 week), 16 week|urinary transferrin, The change in the urinary transferrin from baseline to the end of treatment(16 week), 16 week|insulin, The change in the insulin from baseline to the end of treatment(16 week), 16 week|c-peptide, The change in the c-peptide from baseline to the end of treatment(16 week), 16 week
Sponsor/Collaborators: Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 126
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2014-09
Results First Posted:
Last Update Posted: 2017-05-03
Locations: The Catholic university of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of|Kyungpook National University, DaeGu, Korea, Republic of|Yeungnam University Medical Center, DaeGu, Korea, Republic of|Gil Hospital, Incheon, Korea, Republic of|Inha University Hospital, InCheon, Korea, Republic of|Chonbuk national University Hospital, JeonJu, Korea, Republic of|Eulji Hospital, Seoul, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, Korea, Republic of|Kangnam Sacred Hospital, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Kyunghee Univ Hospital at Kangdong, Seoul, Korea, Republic of|Samsumg Medical Center, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of|Seoul National University Bundang Hospital, SungNam, Korea, Republic of|St. Vincent Hospital, Suwon, Korea, Republic of|UIJEONGBU ST. MARY's HOSPITAL, Uijeongbu, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01726816