Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease

Last updated: September 13, 2023
Sponsor: Yuhan Corporation
Overall Status: Completed

Phase

4

Condition

Intermittent Claudication

Claudication

Peripheral Arterial Occlusive Disease

Treatment

Sarpogrelate

Sarpogrelate SR

Clinical Study ID

NCT06046196
YMC044
  • Ages > 19
  • All Genders

Study 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 artery occlusive disease, based on changes in the Ankle-Brachial Index (ABI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with coronary artery disease or cerebrovascular disease related toarteriosclerosis undergoing or scheduled for surgery or medication treatment
  • Patients with a history of severe heart failure within the 6 months prior to thescreening
  • Patients with a history of bleeding
  • Patients receiving anticoagulants or medications with antiplatelet activity atbaseline
  • Patients diagnosed with peripheral neuropathy and currently taking neuropathic painmedications
  • Patients with infectious or progressive fibrotic diseases such as rheumatoidarthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Sarpogrelate
Phase: 4
Study Start date:
November 18, 2020
Estimated Completion Date:
March 09, 2023

Study 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 three times daily in patients having intermittent claudication among chronic artery occlusive disease. Eligible patients who sign the informed consent form voluntarily will receive the investigational products. Subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. The trial is designed to determine whether Sarpogrelate SR 300mg once daily is inferior to Sarpogrelate 100mg three times daily in terms of changes in the Ankle-Brachial Index (ABI).

Connect with a study center

  • GangNeung Asan Hospital

    Gangneung-si, Gangwon-do 25440
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do 10380
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Korea University ANAM Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan, 44602
    Korea, Republic of

    Site Not Available

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