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

Intermittent Claudication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046196
• Other study ID #: YMC044
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2020
• Est. completion date: March 9, 2023

Study information

• Verified date: September 2023
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Intermittent Claudication

Intervention

Drug:
• Sarpogrelate SR
Sarpogrelate SR 300mg, once a daily, for 24weeks
• Sarpogrelate
Sarpogrelate 100mg, 3 times a day, for 24weeks

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	GangNeung Asan Hospital	Gangneung-si	Gangwon-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University ANAM Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ankle-Brachial Index (ABI)	To evaluate the efficacy following administration of Sarpogrelate SR	from baseline to the 12-week and 24-week
Secondary	Change in Lower Limb Pain Visual Analogue Scale (VAS)	To evaluate the efficacy following administration of Sarpogrelate SR	from baseline to the 12-week and 24-week timepoints
Secondary	Change in Medication Adherence Index (MMAS-8)	To evaluate the efficacy following administration of Sarpogrelate SR	from baseline to the 12-week and 24-week timepoints.
Secondary	Change in Walking Impairment Questionnaire (WIQ)	To evaluate the efficacy following administration of Sarpogrelate SR	from baseline to the 12-week and 24-week timepoints
Secondary	the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness	To evaluate the efficacy following administration of Sarpogrelate SR	at baseline, 12-week, and 24-week timepoints