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
- Conditions
- Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
- Registration Number
- JPRN-jRCT2080220749
- 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
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (ESS), and Safety
- Secondary Outcome Measures
Name Time Method