Status:
COMPLETED
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)
Lead Sponsor:
Yuhan Corporation
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
Eligibility Criteria
Inclusion
- person who signed on ICF
- Type 2 diabetic patient who have microalbuminuria or overt proteinuria
- In case of hypertension patients, who keep the same medication steadily over last 4 weeks
Exclusion
- patients who have hypersensitivity on sarpogrelate or other salicylic acid
- patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
- patients who took other anticoagulant agent within 1 month
- patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
- Type 1 diabetes patients
- Patient who have cardiac or liver problem
- Cr: \>1.8mg/dl or GFR: \<40ml/min
- malignant tumor patients
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2015
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01869881
Start Date
February 1 2013
End Date
January 28 2015
Last Update
April 23 2021
Active Locations (1)
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1
Korea University, Anam
Seoul, South Korea