Back to resultsClinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
Primary Purpose
Arterial Occlusive Diseases, Intermittent Claudication
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate SR
Sarpogrelate
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring Sarpogrelate Sustained Release, Sarpogrelate
Eligibility 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
Sites / Locations
- GangNeung Asan Hospital
- Inje University Ilsan Paik Hospital
- Dong-A University Hospital
- Korea University ANAM Hospital
- Asan Medical Center
- The Catholic University of Korea, Seoul ST. Mary's Hospital
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sarpogrelate SR 300mg, QD
Sarpogrelate 100mg, TID
Arm Description
Sarpogrelate SR 300mg, QD
Sarpogrelate 100mg, TID
Outcomes
Primary Outcome Measures
Change in Ankle-Brachial Index (ABI)
To evaluate the efficacy following administration of Sarpogrelate SR
Secondary Outcome Measures
Change in Lower Limb Pain Visual Analogue Scale (VAS)
To evaluate the efficacy following administration of Sarpogrelate SR
Change in Medication Adherence Index (MMAS-8)
To evaluate the efficacy following administration of Sarpogrelate SR
Change in Walking Impairment Questionnaire (WIQ)
To evaluate the efficacy following administration of Sarpogrelate SR
the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness
To evaluate the efficacy following administration of Sarpogrelate SR
Full Information
NCT ID
NCT06046196
First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Yuhan Corporation
1. Study Identification
Unique Protocol Identification Number
NCT06046196
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Intermittent Claudication
Keywords
Sarpogrelate Sustained Release, Sarpogrelate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sarpogrelate SR 300mg, QD
Arm Type
Experimental
Arm Description
Sarpogrelate SR 300mg, QD
Arm Title
Sarpogrelate 100mg, TID
Arm Type
Active Comparator
Arm Description
Sarpogrelate 100mg, TID
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate SR
Other Intervention Name(s)
Anplag SR Tab. 300mg
Intervention Description
Sarpogrelate SR 300mg, once a daily, for 24weeks
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate
Other Intervention Name(s)
Anplag Tab. 100mg
Intervention Description
Sarpogrelate 100mg, 3 times a day, for 24weeks
Primary Outcome Measure Information:
Title
Change in Ankle-Brachial Index (ABI)
Description
To evaluate the efficacy following administration of Sarpogrelate SR
Time Frame
from baseline to the 12-week and 24-week
Secondary Outcome Measure Information:
Title
Change in Lower Limb Pain Visual Analogue Scale (VAS)
Description
To evaluate the efficacy following administration of Sarpogrelate SR
Time Frame
from baseline to the 12-week and 24-week timepoints
Title
Change in Medication Adherence Index (MMAS-8)
Description
To evaluate the efficacy following administration of Sarpogrelate SR
Time Frame
from baseline to the 12-week and 24-week timepoints.
Title
Change in Walking Impairment Questionnaire (WIQ)
Description
To evaluate the efficacy following administration of Sarpogrelate SR
Time Frame
from baseline to the 12-week and 24-week timepoints
Title
the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness
Description
To evaluate the efficacy following administration of Sarpogrelate SR
Time Frame
at baseline, 12-week, and 24-week timepoints
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jungyo Gwon
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
GangNeung Asan Hospital
City
Gangneung-si
State/Province
Gangwon-do
ZIP/Postal Code
25440
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Korea University ANAM Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44602
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
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