Late phase II study of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210497

Enrollment

200

Registered

2021-12-17

Start date

2022-02-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Arteriosclerosis obliterans (ASO)

Interventions

1.Assigned study drug (NS-304 or placebo) will be orally administered twice daily. 2.Dose Adjustment Period (16 weeks):The investigator (subinvestigator) will start treatment with a dosage regimen of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO) 2.Patients whose ABI is not more than 0.90 at rest. 3.Patients whose mean PWT measured in the treadmill exercise test meets selection criteria.

Exclusion criteria

Exclusion criteria: Patients who have severe ischemia of lower extremities of Stage III or over in Fontaine classification or potentially has severe ischemia of lower extremities

Design outcomes

Primary

Measure	Time frame
Natural log transformed peak walking time (ln PWT)	—

Contacts

Public ContactClinical Operations

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026