Duoble-blind placebo-controlled study (Phase III) of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO)

Duoble-blind placebo-controlled study (Phase III) of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO) - NS304A-P3-1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250134

Enrollment

194

Registered

2026-02-24

Start date

2026-03-05

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

Assigned study drug (NS-304 or placebo) will be orally administered twice daily. Dose Adjustment Period (16 weeks) : The investigator (subinvestigator) will start treatment with a dosage regimen of 20

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO) Patients whose ABI is not more than 0.90 at rest. 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
Change from baseline in Natural log transformed peak walking time (ln PWT)	—

Secondary

Measure	Time frame
1. Change from baseline in peak walking time (PWT) 2. Change rate from baseline in PWT 3. Change from baseline in Natural log transformed claudication onset time (ln COT) 4. Change from baseline in claudication onset time (COT) 5. Change rate from baseline in COT 6. Change from baseline in Resting Ankle-Brachial Index 7 .Change from baseline in WIQ scores 8. Change from baseline in SF-36 scores	—

Contacts

Public ContactOperations Clinical

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