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

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ClinicalTrials.gov Identifier: NCT06046196
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Intermittent Claudication Drug: Sarpogrelate SR Drug: Sarpogrelate Phase 4

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 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-label, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients Having Intermittent Claudication Among Chronic Artery Occlusive Disease
Actual Study Start Date : November 18, 2020
Actual Primary Completion Date : March 9, 2023
Actual Study Completion Date : March 9, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sarpogrelate SR 300mg, QD
Sarpogrelate SR 300mg, QD
 Drug: Sarpogrelate SR
Sarpogrelate SR 300mg, once a daily, for 24weeks
Other Name: Anplag SR Tab. 300mg
Active Comparator: Sarpogrelate 100mg, TID
Sarpogrelate 100mg, TID
 Drug: Sarpogrelate
Sarpogrelate 100mg, 3 times a day, for 24weeks
Other Name: Anplag Tab. 100mg


Outcome Measures
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Primary Outcome Measures :
  1. Change in Ankle-Brachial Index (ABI) [ Time Frame: from baseline to the 12-week and 24-week ]
    To evaluate the efficacy following administration of Sarpogrelate SR


Secondary Outcome Measures :
  1. Change in Lower Limb Pain Visual Analogue Scale (VAS) [ Time Frame: from baseline to the 12-week and 24-week timepoints ]
    To evaluate the efficacy following administration of Sarpogrelate SR

  2. Change in Medication Adherence Index (MMAS-8) [ Time Frame: from baseline to the 12-week and 24-week timepoints. ]
    To evaluate the efficacy following administration of Sarpogrelate SR

  3. Change in Walking Impairment Questionnaire (WIQ) [ Time Frame: from baseline to the 12-week and 24-week timepoints ]
    To evaluate the efficacy following administration of Sarpogrelate SR

  4. the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness [ Time Frame: at baseline, 12-week, and 24-week timepoints ]
    To evaluate the efficacy following administration of Sarpogrelate SR


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046196


Locations
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Korea, Republic of
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, Korea, Republic of, 25440
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
Dong-A University Hospital
Busan, Korea, Republic of, 49201
Korea University ANAM Hospital
Seoul, Korea, Republic of, 02841
Asan Medical Center
Seoul, Korea, Republic of, 05505
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Korea, Republic of, 06591
Ulsan University Hospital
Ulsan, Korea, Republic of, 44602
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Jungyo Gwon Asan Medical Center
More Information
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT06046196    
Other Study ID Numbers: YMC044
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuhan Corporation:
Sarpogrelate Sustained Release
Sarpogrelate
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Sarpogrelate
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs