Overview

This trial is active, not recruiting.

Condition diabetic nephropathy
Treatments anplag(sarpogrelate), placebo
Phase phase 4
Sponsor Yuhan Corporation
Start date February 2013
End date December 2014
Trial size 166 participants
Trial identifier NCT01869881, YCM009

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
anplag(sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
(Placebo Comparator)
placebo
Placebo 100mg 2 tablets, bid, 400mg/day

Primary Outcomes

Measure
Safety
time frame: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
time frame: treatment period(24 weeks)

Secondary Outcomes

Measure
ACR(Urine Albumin/Creatinine ratio)
time frame: Treatment period(24 weeks)
urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen
time frame: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
time frame: treatment period(24 weeks)
ACR(Urine Albumin/Creatinine ratio)
time frame: treatment period(24 weeks)
Creatinine
time frame: treatment period(24 weeks)
PCR(Protein to Creatinine ratio in Urine)
time frame: treatment period(24 weeks)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Principal investigator D.S Choi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Yuhan Corporation.