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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Sarpogrelate SR 300mg, once a daily, for 24weeks
Sarpogrelate 100mg, 3 times a day, for 24weeks
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, South Korea
Korea University ANAM Hospital
Seoul, South Korea
Change in Ankle-Brachial Index (ABI)
To evaluate the efficacy following administration of Sarpogrelate SR
Time frame: from baseline to the 12-week and 24-week
Change in Lower Limb Pain Visual Analogue Scale (VAS)
To evaluate the efficacy following administration of Sarpogrelate SR
Time frame: from baseline to the 12-week and 24-week timepoints
Change in Medication Adherence Index (MMAS-8)
To evaluate the efficacy following administration of Sarpogrelate SR
Time frame: from baseline to the 12-week and 24-week timepoints.
Change in Walking Impairment Questionnaire (WIQ)
To evaluate the efficacy following administration of Sarpogrelate SR
Time frame: from baseline to the 12-week and 24-week timepoints
the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness
To evaluate the efficacy following administration of Sarpogrelate SR
Time frame: at baseline, 12-week, and 24-week timepoints
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Asan Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea