CompletedNCT05083299Updated Jul 3, 2024

Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate

An observational study in Chronic Occlusive Arterial Disease, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 1,003
Ages: 19 Years to 80 Years
Sex: All

Study summary

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 studied

Chronic Occlusive Arterial Disease

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 80 Years
Sexes eligible: All
Sampling method: Probability sample

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%.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 1,003 participants (actual)
Patient registry: No

Groups and cohorts

Anpl-one SR Tablet
Patients who prescribed Anpl-one SR Tablet
Drug: Sarpogrelate

Interventions

DrugSarpogrelate
Anpl-one SR
Also known as: Anpl-one SR

What researchers measure

Primary outcomes

Change in Peripheral Artery Questionnaire
Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline
Time frame: 24 weeks

Secondary outcomes

Peripheral Artery Questionnaire change
Peripheral Artery Questionnaire change at 12 weeks compared to baseline
Time frame: 12 weeks
Peripheral Artery Questionnaire change
Peripheral Artery Questionnaire change at 24 weeks compared to baseline
Time frame: 24 weeks
Change in each domain of Peripheral Artery Questionnaire
Change in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline
Time frame: 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
Time frame: 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
Time frame: 24 weeks

Study locations

1 site

BuKyung Kim
Busan, 49267, South Korea

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Jan 2022, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 6, 2021
First posted: Oct 19, 2021
StartActual: Jan 28, 2020
Primary completionActual: Jan 20, 2022
CompletionActual: Jan 20, 2022
Last update: Jul 3, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05083299
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Responsible party: Sponsor
First posted: Oct 19, 2021
Start date: Jan 28, 2020
Primary completion: Jan 20, 2022
Completion: Jan 20, 2022
Last update: Jul 3, 2024

Study contacts

BuKyung Kim

principal investigator · Kosin University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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