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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06046196
• Collaborator: (none)
• Enrollment: 148
• Locations: 7
• Arms: 2
• Actual Duration (Months): 27.6
• Patients Per Site: 21.1
• Patients Per Site Per Month: 0.8

Study Details

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).

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

• Study Type: Interventional
• 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: Nov 18, 2020
• Actual Primary Completion Date: Mar 9, 2023
• Actual Study Completion Date: Mar 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sarpogrelate SR 300mg, QD 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 Sarpogrelate 100mg, TID	Drug: Sarpogrelate; Sarpogrelate 100mg, 3 times a day, for 24weeks; Other Names: Anplag Tab. 100mg

Outcome Measures

Primary Outcome Measures

1. Change in Ankle-Brachial Index (ABI) [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) [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) [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) [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 [at baseline, 12-week, and 24-week timepoints]

   To evaluate the efficacy following administration of Sarpogrelate SR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GangNeung Asan Hospital	Gangneung-si	Gangwon-do	Korea, Republic of	25440
2	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do	Korea, Republic of	10380
3	Dong-A University Hospital	Busan		Korea, Republic of	49201
4	Korea University ANAM Hospital	Seoul		Korea, Republic of	02841
5	Asan Medical Center	Seoul		Korea, Republic of	05505
6	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul		Korea, Republic of	06591
7	Ulsan University Hospital	Ulsan		Korea, Republic of	44602

Sponsors and Collaborators

• Yuhan Corporation

Investigators

• Principal Investigator: Jungyo Gwon, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT06046196
• Other Study ID Numbers: YMC044
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Intermittent Claudication; Arterial Occlusive Diseases; Sarpogrelate

Study Results

No Results Posted as of Sep 21, 2023