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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Korea University, Anam

Seoul, South Korea