Status:
COMPLETED
Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an anti-platelet agent for the treatment of PAD. SID142 is a new controlled-release product improved patient's ...
Detailed Description
This clinical trial is 12 weeks, multicenter, randomized, double-blind, parallel group, phase 3 study which registered patients in total 19 institutions appointed as national clinical trial institutio...
Eligibility Criteria
Inclusion
- Male or Female outpatients over 20years of age
- patients confirmed to have PAD
- ABI ≤0.9
- Occlusion rate\>50%
- LE PAD with Fontaine stage II/III
- LE pain VAS≥40mm at screening
Exclusion
- Patients who underwent vascular surgery or endovascular procedure for PAD within 1month prior to study. Patients who need vascular surgery or endovascular procedure for PAD during this study also should be excluded.
- Patients with peripheral neuropathy.
- Patients with ischemic heart diseases or underwent percutaneous transluminal coronary angioplasty or coronary artery bypass graft within 6 months prior to study.
- Patients who has diagnosed cerebrovascular diseases within 6 months prior to study.
- Patients with hemorrhage or predisposition to hemorrhage at screening visit.
- Uncontrolled hypertension defined as ≥ 180 mmHg of systolic blood pressure or ≥ 110 mmHg of diastolic blood pressure
Key Trial Info
Start Date :
February 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03318276
Start Date
February 20 2017
End Date
October 15 2018
Last Update
September 20 2019
Active Locations (1)
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1
Yonsei University College of Medicine, Severance Cardiovascular Hospital
Seoul, South Korea