Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
Lead Sponsor:
Yuhan Corporation
Conditions:
Arterial Occlusive Diseases
Intermittent Claudication
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
This clinical trial aims to assess the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic a...
Detailed Description
The clinical trial is a randomized, multicenter, open-label, parallel-group, Phase 4 study conducted to evaluate the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg ...
Eligibility Criteria
Inclusion
- Male or female adults aged ≥ 19
- Diagnosis of chronic arterial occlusive disease
- Experience of intermittent claudication symptoms for at least 3 months
- Receiving Sarpogrelate for a minimum of 4 weeks prior to the baseline
- Lower limb pain measured at VAS 40mm or higher at baseline
Exclusion
- Patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment
- Patients with a history of severe heart failure within the 6 months prior to the screening
- Patients with a history of bleeding
- Patients receiving anticoagulants or medications with antiplatelet activity at baseline
- Patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications
- Patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06046196
Start Date
November 18 2020
End Date
March 9 2023
Last Update
September 21 2023
Active Locations (7)
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1
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, South Korea, 25440
2
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea, 10380
3
Dong-A University Hospital
Busan, South Korea, 49201
4
Korea University ANAM Hospital
Seoul, South Korea, 02841