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

NCT ID: NCT05083299

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1003 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2022-01-20

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.

Conditions

Chronic Occlusive Arterial Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Anpl-one SR Tablet

Patients who prescribed Anpl-one SR Tablet

Sarpogrelate

Intervention Type: DRUG

Anpl-one SR

Interventions

Sarpogrelate

Anpl-one SR

Intervention Type: DRUG

Other Intervention Names

Anpl-one SR

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BuKyung Kim

Role: PRINCIPAL_INVESTIGATOR

Kosin University Hospital

Locations

BuKyung Kim

Busan, , South Korea

Countries

South Korea

Other Identifiers

DWAP_P401

Identifier Type: -

Identifier Source: org_study_id