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

Arteriosclerosis Obliterans Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083299
• Other study ID #: DWAP_P401
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: January 20, 2022

Study information

• Verified date: November 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1884
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Arteriosclerosis Obliterans

Intervention

Drug:
• Sarpogrelate
Anpl-one SR

Locations

Country	Name	City	State
Korea, Republic of	BuKyung Kim	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Peripheral Artery Questionnaire	change in PAQ, scale in numbers, high score means no symptom	at 24 weeks from baseline
Secondary	change in Peripheral Artery Questionnaire	change in PAQ, scale in numbers, high score means no symptom	12 weeks and 24 weeks from baseline