Peripheral Artery Disease, PADPhase 4NCT03509922
A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity
A Phase 4 study testing Anplag Tab. 100mg bid and Anplag Tab. 100mg tid in people with Peripheral Artery Disease, PAD, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Artery Disease, PAD
- What is being tested?
- Anplag Tab. 100mg bid and Anplag Tab. 100mg tid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2018to 5 Mar 2020
- 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
- Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
- tODI < 3 at randomization
- Aged ≥ 19 years
- Written informed consent
Who cannot join
- Patients requiring acute or two or more antiplatelet agents
- Patients requiring anticoagulant therapy
- Patients requiring surgical procedure due to vascular occlusion
- Patients whose results are confirmed at the screening as follows:
- hemoglobin (Hb) test value: male < 13 g/dL, female < 12 g/dL
- platelet count < 60,000/µL
Show all 12Show fewer
- severe renal disease (eGFR < 30 mL/min/1.73 m2)
- Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
- Contraindications stated in the SPC of sarpogrelate
- Patients who are pregnant or planning to become pregnant
- Those participating in other clinical trials with administration of investigational products at the screening
- Those who are deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, Gyeonggido
About this study
Official title: A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease
This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.
- Conditions
- Peripheral Artery Disease, PAD
- Being tested
- Anplag Tab. 100mg bid, Anplag Tab. 100mg tid
- 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.
Anplag Tab. 100mg bidDrug
Also called Sarpogrelate 200mg
sarpogrelate hydrochloride 100mg bid for 24 weeks
Anplag Tab. 100mg tidDrug
Also called Sarpogrelate 300mg
sarpogrelate hydrochloride 100mg tid for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anplag Tab. 100mg bid | Experimental | sarpogrelate hydrochloride 100mg bid for 24 weeks Receives: Drug: Anplag Tab. 100mg bid |
| Anplag Tab. 100mg tid | Experimental | sarpogrelate hydrochloride 100mg tid for 24 weeks Receives: Drug: Anplag Tab. 100mg tid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 24 in tissue oxygen delivery index (tODI)
Measured: baseline, week 24
Secondary outcomes (3)
Change from baseline to week 12 in tODI
Measured: baseline, week 12
Proportion of subjects with tODI elevated by 20% or more
Measured: baseline, week 12, week 24
Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)
Measured: baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start11 Oct 2018
- Primary completion26 Dec 2019
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease, PADStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509922
- Sponsor's protocol ID
- YMC036
- Status last verified
- Jun 2020
- First submitted
- 17 Apr 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03509922
- Acronym / sponsor ID
- YMC036
- Conditions
- Peripheral Artery Disease, PAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 26 Apr 2018 (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 study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anplag Tab. 100mg bid | Experimental | Drug: Anplag Tab. 100mg bidsarpogrelate hydrochloride 100mg bid for 24 weeks |
| Anplag Tab. 100mg tid | Experimental | Drug: Anplag Tab. 100mg tidsarpogrelate hydrochloride 100mg tid for 24 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
- tODI < 3 at randomization
- Aged ≥ 19 years
- Written informed consent
Key exclusion criteria (12 listed)
- Patients requiring acute or two or more antiplatelet agents
- Patients requiring anticoagulant therapy
- Patients requiring surgical procedure due to vascular occlusion
- Patients whose results are confirmed at the screening as follows:
- Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
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 |
|---|---|---|
| Anplag Tab. 100mg bidAlso: Sarpogrelate 200mgsarpogrelate hydrochloride 100mg bid for 24 weeks | Drug | Anplag Tab. 100mg bid |
| Anplag Tab. 100mg tidAlso: Sarpogrelate 300mgsarpogrelate hydrochloride 100mg tid for 24 weeks | Drug | Anplag Tab. 100mg tid |
Primary outcome
Change from baseline to week 24 in tissue oxygen delivery index (tODI)
Time frame: baseline, week 24
3 secondary outcomes
Change from baseline to week 12 in tODI
Time frame: baseline, week 12
Proportion of subjects with tODI elevated by 20% or more
Time frame: baseline, week 12, week 24
Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)
Time frame: baseline, week 24
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 23 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anplag Tab. 100mg bid and Anplag Tab. 100mg tid in people with Peripheral Artery Disease, PAD, run by Yuhan Corporation 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 4 inclusion and 12 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 23 Jun 2020. 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 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 from baseline to week 24 in tissue oxygen delivery index (tODI) (time frame: baseline, week 24). 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 23 Jun 2020.