Peripheral Arterial DiseasePhase 3NCT03318276
Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease
A Phase 3 study testing SID142 and Rinexin® Tab in people with Peripheral Arterial Disease, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- SID142 and Rinexin® Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Feb 2017to 15 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine, Severance Cardiovascular Hospital
Seoul
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group and Phase III Clinical Trial to Evaluate in Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease
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
Read the detailed description
This clinical trial is 12 weeks, multicenter, randomized, double-blind, parallel group, phase 3 study which registered patients in total 19 institutions appointed as national clinical trial institution, it was conducted by receiving IRB(institutional review board) approval from each institutions.
Target patients were aged over 20 years old male or female lower limb peripheral artery occlusion patients with fontaine stage II/III, who has lower limb pain. Lower limb pain degree is over 40 mm evaluated by VAS at screening, and ABI (ankle-brachial index) ≤0.9 or stenosis rate over >50%, diagnosed with PAD and voluntarily agreed to participate in clinical study and signed study consent form. Study subjects who met subjects criteria and recruited were total 170 subjects. Selected subjects were stratified by 1:1 ratio and randomly assigned to investigational product or comparator.
Investigational product was SID142 and comparator was Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg). Administration period to subjects was 12 weeks, study group took investigational product, SID1421 tab once(morning) and took placebo 1 tab/once, 2 times/day, and comparator group took investigational product, Rinexin® Tab 1 tab/once, 2 times/day and took placebo 1 tab once(morning).
Efficacy and Safety Assessment Parameter Subjects visited at 4, 8, and 12 weeks including baseline visit (visit 2) at 4 weeks interval and took efficacy and safety.
Variation in lower limb pain (VAS) comparing baseline with 12 weeks point as a primary efficacy Assessment parameter, variation in lower limb pain (VAS) comparing baseline with 4, 8 weeks, ankle brachial pressure index (ABI), ankle systolic pressure (ASP), Maximum Walking Distance (MWD), Pain Free Walking Distance (PFWD), andInvestigator's global assessment (5-point scale) as secondary efficacy assessment parameters, efficacy was measured. Pain and coldness test was measured using pain and coldness felt by subject 24 hours prior to the visit, MWD and PFWD was measured only on subjects who was determined to be possible to measure. Also, adverse event, laboratory test, vital sign, were conducted for safety assessment. Physical test and vital sign were conducted at screening visit, administration begins, 4, 8, and 12 weeks and urine pregnancy test and laboratory test were conducted at screening visits and 12 weeks. ECG test was conducted at screening visit, 4, 8, and 12 weeks after. Laboratory test criteria were hematological test, blood chemical test, blood coagulation test and urine test.
- Conditions
- Peripheral Arterial Disease
- Being tested
- SID142, Rinexin® Tab
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SID142Drug
Also called Placebo (For Rinexin® Tab)
SID142 is administrated to patients with PAD for 12 weeks
Rinexin® TabDrug
Also called Placebo (For SID142)
Rinexin® Tab is administrated to patients with PAD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| SID142 | Experimental | Patients administrate SID142 (Cilostazol 200mg, Ginkgo biloba leaf extract 160mg) once a day for 12 weeks Receives: Drug: SID142 |
| Rinexin® Tab | Active comparator | Patients administrate Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) twice a day for 12 weeks Receives: Drug: Rinexin® Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start20 Feb 2017
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donghoon Choi, Principal investigator, Yonsei University College of Medicine, Severance Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318276
- Sponsor's protocol ID
- SID142_ATP_III_2015
- Status last verified
- Sep 2018
- First submitted
- 18 Oct 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35410753
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group and Phase III Clinical Trial to Evaluate in Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease
- ClinicalTrials.gov ID
- NCT03318276
- Acronym / sponsor ID
- SID142_ATP_III_2015
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This clinical trial is 12 weeks, multicenter, randomized, double-blind, parallel group, phase 3 study which registered patients in total 19 institutions appointed as national clinical trial institution, it was conducted by receiving IRB(institutional review board) approval from each institutions.
Target patients were aged over 20 years old male or female lower limb peripheral artery occlusion patients with fontaine stage II/III, who has lower limb pain. Lower limb pain degree is over 40 mm evaluated by VAS at screening, and ABI (ankle-brachial index) ≤0.9 or stenosis rate over >50%, diagnosed with PAD and voluntarily agreed to participate in clinical study and signed study consent form. Study subjects who met subjects criteria and recruited were total 170 subjects. Selected subjects were stratified by 1:1 ratio and randomly assigned to investigational product or comparator.
Investigational product was SID142 and comparator was Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg). Administration period to subjects was 12 weeks, study group took investigational product, SID1421 tab once(morning) and took placebo 1 tab/once, 2 times/day, and comparator group took investigational product, Rinexin® Tab 1 tab/once, 2 times/day and took placebo 1 tab once(morning).
Efficacy and Safety Assessment Parameter Subjects visited at 4, 8, and 12 weeks including baseline visit (visit 2) at 4 weeks interval and took efficacy and safety.
Variation in lower limb pain (VAS) comparing baseline with 12 weeks point as a primary efficacy Assessment parameter, variation in lower limb pain (VAS) comparing baseline with 4, 8 weeks, ankle brachial pressure index (ABI), ankle systolic pressure (ASP), Maximum Walking Distance (MWD), Pain Free Walking Distance (PFWD), andInvestigator's global assessment (5-point scale) as secondary efficacy assessment parameters, efficacy was measured. Pain and coldness test was measured using pain and coldness felt by subject 24 hours prior to the visit, MWD and PFWD was measured only on subjects who was determined to be possible to measure. Also, adverse event, laboratory test, vital sign, were conducted for safety assessment. Physical test and vital sign were conducted at screening visit, administration begins, 4, 8, and 12 weeks and urine pregnancy test and laboratory test were conducted at screening visits and 12 weeks. ECG test was conducted at screening visit, 4, 8, and 12 weeks after. Laboratory test criteria were hematological test, blood chemical test, blood coagulation test and urine test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SID142 | Experimental | Drug: SID142Patients administrate SID142 (Cilostazol 200mg, Ginkgo biloba leaf extract 160mg) once a day for 12 weeks |
| Rinexin® Tab | Active comparator | Drug: Rinexin® TabPatients administrate Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) twice a day for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female outpatients over 20years of age
- patients confirmed to have PAD
- LE PAD with Fontaine stage II/III
- LE pain VAS≥40mm at screening
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SID142Also: Placebo (For Rinexin® Tab)SID142 is administrated to patients with PAD for 12 weeks | Drug | SID142 |
| Rinexin® TabAlso: Placebo (For SID142)Rinexin® Tab is administrated to patients with PAD for 12 weeks | Drug | Rinexin® Tab |
Primary outcome
Variation in lower limb pain (VAS)
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 35410753Kook 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donghoon Choi principal investigator
Yonsei University College of Medicine, Severance Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SID142 and Rinexin® Tab in people with Peripheral Arterial Disease, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in lower limb pain (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.