Overview

Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes (SONATA Study)

Status:
Completed
Trial end date:
2015-01-28
Target enrollment:
0
Participant gender:
All
Summary
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yuhan Corporation
Treatments:
Sarpogrelate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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