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Clinical Trial Details

Trial ID: L3985
Source ID: NCT01869881
Associated Drug: Anplag(Sarpogrelate)
Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Nephropathy
Interventions: DRUG: Anplag(Sarpogrelate)|DRUG: Placebo
Outcome Measures: Primary: ACR(Urine Albumin/Creatinine ratio), change of percentage, treatment period(24 weeks) | Secondary: ACR(Urine Albumin/Creatinine ratio), improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(\<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product), Treatment period(24 weeks)|urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen, changes comparing to baseline data, treatment period(24 weeks)|ACR(Urine Albumin/Creatinine ratio), improved amount comparing to baseline data, treatment period(24 weeks)|ACR(Urine Albumin/Creatinine ratio), rate of normalized ACR, treatment period(24 weeks)|Creatinine, improved amount of Creatinine, treatment period(24 weeks)|PCR(Protein to Creatinine ratio in Urine), improved rate comparing to baseline data, treatment period(24 weeks)
Sponsor/Collaborators: Sponsor: Yuhan Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 151
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-02-01
Completion Date: 2015-01-28
Results First Posted:
Last Update Posted: 2021-04-23
Locations: Korea University, Anam, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01869881