NIPH Clinical Trials Search

Duoble-blind placebo-controlled 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	05/03/2026
Target sample size	194
Countries of recruitment
Study type	Interventional
Intervention(s)	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 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.

Outcome(s)

Primary Outcome	Change from baseline in Natural log transformed peak walking time (ln PWT)
Secondary Outcome	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

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 mean 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