Overview

A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Status:
Completed

Trial end date:
2020-03-05

Target enrollment:
0

Participant gender:
All

Summary

This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yuhan Corporation

Treatments:

Sarpogrelate

Criteria

Inclusion Criteria:

1. Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's
disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with
ischemic symptoms such as ulcers, pain, cold sensation, etc.)

2. tODI < 3 at randomization

3. Aged ≥ 19 years

4. Written informed consent

Exclusion Criteria:

1. Patients requiring acute or two or more antiplatelet agents

2. Patients requiring anticoagulant therapy

3. Patients requiring surgical procedure due to vascular occlusion

4. Patients whose results are confirmed at the screening as follows:

- hemoglobin (Hb) test value: male < 13 g/dL, female < 12 g/dL

- platelet count < 60,000/µL

- severe renal disease (eGFR < 30 mL/min/1.73 m2)

5. Patients with a history of cerebrovascular and cardiovascular complications (cerebral
infarction, transient ischemic attack, myocardial infarction, unstable angina,
coronary artery bypass, percutaneous coronary intervention) within the last 6 months

6. Contraindications stated in the SPC of sarpogrelate

7. Patients who are pregnant or planning to become pregnant

8. Those participating in other clinical trials with administration of investigational
products at the screening

9. Those who are deemed to be ineligible to participate in the trial by investigator