Status:
UNKNOWN
YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
Lead Sponsor:
Han Wha Pharma Co., Ltd.
Conditions:
Diabetic Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the treatment of endothelial dysfunction in patients with diabetes mellitus.
Detailed Description
The primary purpose of this study is to demonstrate superior effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean change difference o...
Eligibility Criteria
Inclusion
- Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent), Endothelial dysfunction: FMD below 6.7%, LDL cholesterol level less than 140 mg/dl, Patients agreed to Informed Consent Form
Exclusion
- (Key exclusion criteria) Uncontrolled arterial hypertension (above 139/90 mmHg) or hypotension (below 80/50 mmHg), Severe diabetic complication: diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, diabetic vascular complications
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01836172
Start Date
April 1 2013
End Date
January 1 2017
Last Update
August 17 2016
Active Locations (1)
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1
Internal medicine, Seoul National University Hospital
Seoul, Seoul, South Korea, 110-744