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

NCT03318276 | Completed Phase 3

• 1 other identifier: SID142_ATP_III_2015
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Variation in lower limb pain (VAS)

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure lower limb pain that is believed to range across a continuum of values. The amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. VAS is a 100mm horizontal line. The patient marks on the line the point that they feel represents their perception of their state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the subject marks. The higher the score, the more severe the pain.

  12 weeks

Study Arms (2)

SID142

EXPERIMENTAL

Patients administrate SID142 (Cilostazol 200mg, Ginkgo biloba leaf extract 160mg) once a day for 12 weeks

Drug: SID142

Rinexin® Tab

ACTIVE COMPARATOR

Patients administrate Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) twice a day for 12 weeks

Drug: Rinexin® Tab

Interventions

SID142 DRUG

SID142 is administrated to patients with PAD for 12 weeks

Also known as: Placebo (For Rinexin® Tab)

SID142

Rinexin® Tab DRUG

Rinexin® Tab is administrated to patients with PAD for 12 weeks

Also known as: Placebo (For SID142)

Rinexin® Tab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female outpatients over 20years of age
• patients confirmed to have PAD
• ABI ≤0.9
• Occlusion rate\>50%
• LE PAD with Fontaine stage II/III
• LE pain VAS≥40mm at screening

You may not qualify if:

• Patients who underwent vascular surgery or endovascular procedure for PAD within 1month prior to study. Patients who need vascular surgery or endovascular procedure for PAD during this study also should be excluded.
• Patients with peripheral neuropathy.
• Patients with ischemic heart diseases or underwent percutaneous transluminal coronary angioplasty or coronary artery bypass graft within 6 months prior to study.
• Patients who has diagnosed cerebrovascular diseases within 6 months prior to study.
• Patients with hemorrhage or predisposition to hemorrhage at screening visit.
• Uncontrolled hypertension defined as ≥ 180 mmHg of systolic blood pressure or ≥ 110 mmHg of diastolic blood pressure

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Yonsei University College of Medicine, Severance Cardiovascular Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kook H, Yu CW, Choi D, Ahn TH, Chang K, Cho JM, Kim SJ, Park CG, Cho DK, Kim SH, Lee HC, Jin HY, Chae IH, Kwon K, Ahn SG, Kim JH, Lee SR, Kim JS, Kim SY, Lim SW. Efficacy and Safety of SID142 in Patients With Peripheral Arterial Disease: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Clinical Trial. Clin Ther. 2022 Apr;44(4):508-528. doi: 10.1016/j.clinthera.2022.01.016. Epub 2022 Apr 9.

  PMID: 35410753 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Donghoon Choi

  Yonsei University College of Medicine, Severance Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: February 20, 2017
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: September 20, 2019

Record last verified: 2018-09

Locations

KR (1)