drugset / Trial / NCT03318276

Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease

NCT03318276 ↗

Phase 3 Completed 170 enrolled SK Chemicals Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an anti-platelet agent for the treatment of PAD. SID142 is a new controlled-release product improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim of this study was to compare the efficacy and safety of SID142 and Rinexin® Tab in patients with PAD

Timeline

Start
2017-02-20
Primary completion
2018-10-15
Completion
2018-10-15

Outcome

Met primary endpoint

paper Analysis of the change in lower extremity pain at 12 weeks compared with baseline revealed that SID142 was not inferior to Renexin PMID 35410753 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilostazol Small molecule 100 mg —
Subject Cilostazol Small molecule 200 mg —
Subject Ginkgo Biloba Extract Traditional medicine (herbal / TCM) 80 mg —
Subject Ginkgo Biloba Extract Traditional medicine (herbal / TCM) 160 mg —