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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Yuhan Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01869881
First Posted: June 5, 2013
Last Update Posted: July 10, 2014
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.
Information provided by (Responsible Party):
Yuhan Corporation
  Purpose
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.

Condition Intervention Phase
Diabetic Nephropathy Drug: Anplag(Sarpogrelate) Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: treatment period(24 weeks) ]
    adverse event and rate of adverse event

  • ACR(Urine Albumin/Creatinine ratio) [ Time Frame: treatment period(24 weeks) ]
    change of percentage


Secondary Outcome Measures:
  • 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)

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

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

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

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

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


Estimated Enrollment: 166
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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
Korea, Republic of
Korea University, Anam
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: D.S Choi, MD, PhD Korea University Hospital, Anam
  More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01869881     History of Changes
Other Study ID Numbers: YCM009
First Submitted: May 31, 2013
First Posted: June 5, 2013
Last Update Posted: July 10, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic 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


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