We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01869881
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Anplag(Sarpogrelate) Drug: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : November 17, 2014
Actual Study Completion Date : January 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Sarpogrelate Drug: Anplag(Sarpogrelate)
Sarpogrelate 100mg 2 tablets, bid, 400mg/day
Placebo Comparator: Placebo Drug: Placebo
Placebo 100mg 2 tablets, bid, 400mg/day


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
    change of percentage


Secondary Outcome Measures :
  1. ACR(Urine Albumin/Creatinine ratio) [ Time Frame: Treatment period(24 weeks) ]
    improvement efficiency rate of ACR comparing to baseline Definition of improvement efficiency : ACR become normal(<20mg/g Cr) or ACR is decreased more than 50% comparing to data before taking IP(Investigators' product)

  2. urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen [ Time Frame: treatment period(24 weeks) ]
    changes comparing to baseline data

  3. ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
    improved amount comparing to baseline data

  4. ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
    rate of normalized ACR

  5. Creatinine [ Time Frame: treatment period(24 weeks) ]
    improved amount of Creatinine

  6. PCR(Protein to Creatinine ratio in Urine) [ Time Frame: treatment period(24 weeks) ]
    improved rate comparing to baseline data


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869881


Locations
Layout table for location information
Korea, Republic of
Korea University, Anam
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Layout table for investigator information
Principal Investigator: D.S Choi, MD, PhD Korea University Hospital, Anam
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01869881    
Other Study ID Numbers: YCM009
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Sarpogrelate
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs