A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

NCT03509922 | Completed Phase 4

• 1 other identifier: YMC036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Artery Disease, PAD

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in tissue oxygen delivery index (tODI)

  baseline, week 24

Secondary Outcomes (3)

• Change from baseline to week 12 in tODI

  baseline, week 12

• Proportion of subjects with tODI elevated by 20% or more

  baseline, week 12, week 24

• Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)

  baseline, week 24

Study Arms (2)

Anplag Tab. 100mg bid

EXPERIMENTAL

sarpogrelate hydrochloride 100mg bid for 24 weeks

Drug: Anplag Tab. 100mg bid

Anplag Tab. 100mg tid

EXPERIMENTAL

sarpogrelate hydrochloride 100mg tid for 24 weeks

Drug: Anplag Tab. 100mg tid

Interventions

Anplag Tab. 100mg bid DRUG

sarpogrelate hydrochloride 100mg bid for 24 weeks

Also known as: Sarpogrelate 200mg

Anplag Tab. 100mg bid

Anplag Tab. 100mg tid DRUG

sarpogrelate hydrochloride 100mg tid for 24 weeks

Also known as: Sarpogrelate 300mg

Anplag Tab. 100mg tid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• tODI \< 3 at randomization
• Aged ≥ 19 years
• Written informed consent

You may not qualify if:

• Patients requiring acute or two or more antiplatelet agents
• Patients requiring anticoagulant therapy
• Patients requiring surgical procedure due to vascular occlusion
• 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)
• 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
• Contraindications stated in the SPC of sarpogrelate
• Patients who are pregnant or planning to become pregnant
• Those participating in other clinical trials with administration of investigational products at the screening
• Those who are deemed to be ineligible to participate in the trial by investigator

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

BID protein, human; sarpogrelate

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 26, 2018
• Study Start: October 11, 2018
• Primary Completion: December 26, 2019
• Study Completion: March 5, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

KR (1)