臨床研究等提出・公開システム

Date of registration	Feb. 24, 2026
Last modified on	May. 11, 2026
Trial ID	jRCT2071250135

Scientific Title	A Long-term study (Phase III) of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO) (NS304A-P3-2)
Public Title	A Long-term study (Phase III) of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO) (NS304A-P3-2)

Contact for Scientific Queries	Name	Higashioka Masaya
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp
Contact for Public Queries	Name	Clinical Development Operations
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 01, 2026
Actual date of first enrollment		Mar. 30, 2026
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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 PWT measured in the treadmill exercise test meets selection 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
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Arteriosclerosis obliterans (ASO)
Intervention(s)		NS-304 will be orally administered twice daily. Dose Adjustment Period (16 weeks) : The investigator (subinvestigator) will start treatment with a dosage regimen of 200 mcg per dose and will be allowed to increase the dose to a maximum of 1200 mcg per dose while confirming the tolerability in patients. Dose Maintenance Period (16 weeks) : The maintenance dose determined for each patient in the Dose Adjustment Period will be administered. Long-term administration Period (20 weeks) : The maintenance dose determined for each patient in the Dose Adjustment Period will be administered.Long-term administration Period (20 weeks) : The maintenance dose determined for each patient in the Dose Adjustment Period will be administered.
Primary Outcome(s)		Safety of Long-Term Administration (52 weeks) of NS-304
Secondary Outcome(s)		Efficacy of Long-Term Administration (52 weeks) of NS-304

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Name of Certified Review Board	Red Cross Kumamoto Hospital Institutional Review Board
Address	2-1-1 Nagamine Minami, Higashi-ku, Kumamoto City, Kumamoto Prefecture, Kumamoto
Telephone	+81-96-384-2111
Approval Status	Approval
Date of approval	Feb. 04, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 11, 2026	(this page)	Changes
1	Feb. 24, 2026	Detail

List of change history