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Phase 3 clinical study of AFT-801(confirmatory study 0305) Double-blind, placebo-controlled study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients

Phase 3 clinical study of AFT-801(confirmatory study 0305) Double-blind, placebo-controlled study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220749
Enrollment
Unknown
Registered
2009-06-12
Start date
2009-06-12
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

Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients

Interventions

investigational material(s) Generic name etc : AFT-801 (Modafinil) INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational

Sponsors

Mitsubishi Tanabe Pharma Alfresa Pharma Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with a confirmed diagnosis of obstructive sleep apnea syndrome Patients who have used a CPAP machine for at least three months and are able to continue its use during the study period

Exclusion criteria

Exclusion criteria: Patients with existing narcolepsy, periodic limb movement disorder or central sleep apnea syndrome Patients who work irregular hours or at night Patients with chronic lack of sleep or irregular bedtime, etc.

Design outcomes

Primary

MeasureTime frame
Efficacy (ESS), and Safety—

Contacts

Public Contact; ;

Alfresa Pharma corporation;Mitsubishi Tanabe Pharma Corporation.

;;

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026