Arterial Occlusive DiseasesPhase 4NCT06046196
Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
A Phase 4 study testing Sarpogrelate SR and Sarpogrelate in people with Arterial Occlusive Diseases and Intermittent Claudication, run by Yuhan Corporation at 7 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arterial Occlusive Diseases, Intermittent Claudication
- What is being tested?
- Sarpogrelate SR and Sarpogrelate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 18 Nov 2020to 9 Mar 2023
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Dong-A University Hospital
Busan, 49201
GangNeung Asan Hospital
Gangneung-si, Gangwon-do, 25440
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
Korea University ANAM Hospital
Seoul, 02841
Asan Medical Center
Seoul, 05505
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Ulsan University Hospital
Ulsan, 44602
About this study
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
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).
Read the detailed 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).
- Being tested
- Sarpogrelate SR, Sarpogrelate
- Keywords
- Sarpogrelate Sustained Release, Sarpogrelate
- Medical subject headings
- Arterial Occlusive Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarpogrelate SRDrug
Also called Anplag SR Tab. 300mg
Sarpogrelate SR 300mg, once a daily, for 24weeks
SarpogrelateDrug
Also called Anplag Tab. 100mg
Sarpogrelate 100mg, 3 times a day, for 24weeks
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate SR 300mg, QD | Experimental | Sarpogrelate SR 300mg, QD Receives: Drug: Sarpogrelate SR |
| Sarpogrelate 100mg, TID | Active comparator | Sarpogrelate 100mg, TID Receives: Drug: Sarpogrelate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ankle-Brachial Index (ABI)
To evaluate the efficacy following administration of Sarpogrelate SR
Measured: from baseline to the 12-week and 24-week
Secondary outcomes (4)
Change in Lower Limb Pain Visual Analogue Scale (VAS)
To evaluate the efficacy following administration of Sarpogrelate SR
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline, 12-week, and 24-week timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Nov 2020
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jungyo Gwon, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046196
- Sponsor's protocol ID
- YMC044
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06046196
- Acronym / sponsor ID
- YMC044
- Keywords
- Sarpogrelate Sustained Release, Sarpogrelate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 21 Sep 2023 (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.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate SR 300mg, QD | Experimental | Drug: Sarpogrelate SRSarpogrelate SR 300mg, QD |
| Sarpogrelate 100mg, TID | Active comparator | Drug: SarpogrelateSarpogrelate 100mg, TID |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Sarpogrelate SRAlso: Anplag SR Tab. 300mgSarpogrelate SR 300mg, once a daily, for 24weeks | Drug | Sarpogrelate SR 300mg, QD |
| SarpogrelateAlso: Anplag Tab. 100mgSarpogrelate 100mg, 3 times a day, for 24weeks | Drug | Sarpogrelate 100mg, TID |
Primary outcome
Change in Ankle-Brachial Index (ABI)
Time frame: from baseline to the 12-week and 24-week
To evaluate the efficacy following administration of Sarpogrelate SR
4 secondary outcomes
Change in Lower Limb Pain Visual Analogue Scale (VAS)
Time frame: from baseline to the 12-week and 24-week timepoints
Change in Medication Adherence Index (MMAS-8)
Time frame: from baseline to the 12-week and 24-week timepoints.
Change in Walking Impairment Questionnaire (WIQ)
Time frame: from baseline to the 12-week and 24-week timepoints
the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness
Time frame: at baseline, 12-week, and 24-week timepoints
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jungyo Gwon principal investigator
Asan Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sarpogrelate SR and Sarpogrelate in people with Arterial Occlusive Diseases and Intermittent Claudication, run by Yuhan Corporation at 7 sites 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 5 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Ankle-Brachial Index (ABI) (time frame: from baseline to the 12-week and 24-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.