NIPH Clinical Trials Search

A Long-term study (Phase III) of NS-304 in patients with intermittent claudication (IC) resulting from arteriosclerosis obliterans (ASO)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Arteriosclerosis obliterans (ASO)
Date of first enrollment	30/03/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
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.

Outcome(s)

Primary Outcome	Safety of Long-Term Administration (52 weeks) of NS-304
Secondary Outcome	Efficacy of Long-Term Administration (52 weeks) of NS-304

Key inclusion & exclusion criteria

Age minimum	>= 40age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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