Chronic Occlusive Arterial DiseaseNCT05083299
Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate
An observational study of Chronic Occlusive Arterial Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Occlusive Arterial Disease
- What is being tested?
- Sarpogrelate
- Type of treatment
- Pill or oral medicine
- How many people
- 1,003 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2020to 20 Jan 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: As a result of the calculation for the number of survey subjects in this study, a total of 1507 subjects are required, and a total of 1,884 subjects are planned to be recruited in consideration of the dropout rate of 20%.
Who may be able to join
- Adults over 19 and under 80 years of age.
- Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.).
- Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.
Who cannot join
- Patient who is expected to have less than two years of life expectancy.
- Patient who have bleeding within a week of participation in the study
- Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
- A female patient who is likely to be pregnant or pregnant.
- Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
- Patients with severe renal disease and liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.
Read the detailed description
The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.
- Conditions
- Chronic Occlusive Arterial Disease
- Being tested
- Sarpogrelate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarpogrelateDrug
Also called Anpl-one SR
Anpl-one SR
| Study group | Role | What they receive |
|---|---|---|
| Anpl-one SR Tablet | Patients who prescribed Anpl-one SR Tablet Receives: Drug: Sarpogrelate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral Artery Questionnaire
Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline
Measured: 24 weeks
Secondary outcomes (5)
Peripheral Artery Questionnaire change
Peripheral Artery Questionnaire change at 12 weeks compared to baseline
Measured: 12 weeks
Peripheral Artery Questionnaire change
Peripheral Artery Questionnaire change at 24 weeks compared to baseline
Measured: 24 weeks
Change in each domain of Peripheral Artery Questionnaire
Change in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline
Measured: 24 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 12 weeks
Measured: 12 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start28 Jan 2020
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Occlusive Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BuKyung Kim, Principal investigator, Kosin University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083299
- Sponsor's protocol ID
- DWAP_P401
- Status last verified
- Jul 2024
- First submitted
- 6 Oct 2021
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05083299
- Acronym / sponsor ID
- DWAP_P401
- Conditions
- Chronic Occlusive Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 19 Oct 2021 (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.
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.
Detailed description
The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anpl-one SR Tablet | – | Drug: SarpogrelatePatients who prescribed Anpl-one SR Tablet |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- As a result of the calculation for the number of survey subjects in this study, a total of 1507 subjects are required, and a total of 1,884 subjects are planned to be recruited in consideration of the dropout rate of 20%.
Key inclusion criteria (3 listed)
- Adults over 19 and under 80 years of age.
- Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.).
- Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.
Key exclusion criteria (6 listed)
- Patient who is expected to have less than two years of life expectancy.
- Patient who have bleeding within a week of participation in the study
- Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
- A female patient who is likely to be pregnant or pregnant.
- Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
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 |
|---|---|---|
| SarpogrelateAlso: Anpl-one SRAnpl-one SR | Drug | Anpl-one SR Tablet |
Primary outcome
Change in Peripheral Artery Questionnaire
Time frame: 24 weeks
Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline
5 secondary outcomes
Peripheral Artery Questionnaire change
Time frame: 12 weeks
Peripheral Artery Questionnaire change
Time frame: 24 weeks
Change in each domain of Peripheral Artery Questionnaire
Time frame: 24 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
Time frame: 12 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
Time frame: 24 weeks
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 3 Jul 2024.
- 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.
BuKyung Kim principal investigator
Kosin University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Occlusive Arterial Disease, run by Daewoong Pharmaceutical 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 3 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 3 Jul 2024. 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.
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 Peripheral Artery Questionnaire (time frame: 24 weeks). 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 3 Jul 2024.