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

September 13, 2023 updated by: Yuhan Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44602
        • Ulsan University Hospital
    • Gangwon-do
      • Gangneung-si, Gangwon-do, Korea, Republic of, 25440
        • GangNeung Asan Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sarpogrelate SR 300mg, QD
Drug: Sarpogrelate SR
Sarpogrelate SR 300mg, once a daily, for 24weeks
Other Names:
  • Anplag SR Tab. 300mg
Active Comparator: Sarpogrelate 100mg, TID
Drug: Sarpogrelate
Sarpogrelate 100mg, 3 times a day, for 24weeks
Other Names:
  • Anplag Tab. 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to the 12-week and 24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to the 12-week and 24-week timepoints
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
from baseline to the 12-week and 24-week timepoints.
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
from baseline to the 12-week and 24-week timepoints
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
at baseline, 12-week, and 24-week timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Jungyo Gwon, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMC044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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