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

Yuhan

Status and phase: Completed; Phase 4

Conditions: Diabetic Nephropathy

Treatments: Drug: Anplag(Sarpogrelate); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01869881

YCM009

Details and patient eligibility

About

Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.

Enrollment: 151 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 2 patient groups, including a placebo group

Sarpogrelate

Active Comparator group

Treatment:

Drug: Anplag(Sarpogrelate)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo