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

JRCT ID: jRCT2031210497

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Arteriosclerosis obliterans (ASO)
• Date of first enrollment: 17/02/2022
• Target sample size: 200
• Study type: Interventional

Intervention(s)

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 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.
3.Dose Maintenance Period (16 weeks):The maintenance dose determined for each patient in the Dose Adjustment Period will be administered.

Outcome(s)

• Primary Outcome: Natural log transformed peak walking time (ln PWT)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

• 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

Related Information

• Primary Sponsor: Taira Masafumi