Skip to content

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

Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05083299
Enrollment
1003
Registered
2021-10-19
Start date
2020-01-28
Completion date
2022-01-20
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Occlusive Arterial Disease

Brief summary

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.

Interventions

Anpl-one SR

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years

Inclusion criteria

1. Adults over 19 and under 80 years of age. 2. 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.). 3. 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

1. Patient who is expected to have less than two years of life expectancy. 2. Patient who have bleeding within a week of participation in the study 3. Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.). 4. A female patient who is likely to be pregnant or pregnant. 5. Female patients who are lactating or are scheduled to be lactated at the time of participation in the study. 6. Patients with severe renal disease and liver disease.

Design outcomes

Primary

MeasureTime frameDescription
Change in Peripheral Artery Questionnaire24 weeksChange in Peripheral Artery Questionnaire at 24 weeks compared to baseline

Secondary

MeasureTime frameDescription
Peripheral Artery Questionnaire change12 weeksPeripheral Artery Questionnaire change at 12 weeks compared to baseline
Change in each domain of Peripheral Artery Questionnaire24 weeksChange in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients12 weeksConfirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026