To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
NCT ID: NCT01935167
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2013-10-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A Group
DW1029M 600mg for 24 weeks
DW1029M 600mg
DW1029M 150mg 2 tablets b.i.d
B Group
DW1029M 1200mg for 24 weeks
DW1029M 1200mg
DW1029M 300mg 2 tablets b.i.d
C Group
Placebo for 24 weeks
Placebo
Placebo 2 tablets b.i.d.
Interventions
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DW1029M 600mg
DW1029M 150mg 2 tablets b.i.d
DW1029M 1200mg
DW1029M 300mg 2 tablets b.i.d
Placebo
Placebo 2 tablets b.i.d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has confirmed microalbuminuria 30 \~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \~ 299㎍/㎎creatinine during screening period
* Blood Pressure(BP) ≤ 150 / 90 mmHg
* estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
* Hemoglobin A1c(HbA1c) ≤ 9%
* Low density lipoprotein(LDL-C) ≤ 130mg/dl
Exclusion Criteria
* Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \[NOTE\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
* cardiovascular disease prior to 3 months as follows \[NOTE\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
30 Years
ALL
No
Sponsors
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Dong Wha Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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MoonKyu Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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DongWha Pharm
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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DW1029M
Identifier Type: -
Identifier Source: org_study_id
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