Phase III clinical study of AFT-801 (long-term administration study) Open-label study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
Phase 3
- Conditions
- Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
- Registration Number
- JPRN-jRCT2080220353
- Lead Sponsor
- Mitsubishi Tanabe Pharma Alfresa Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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, Patients aged >=20 and =<70 years, etc.
[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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Efficacy (ESS) and Pharmacokinetics
- Secondary Outcome Measures
Name Time Method