check_circleStudy Completed
Sleep Apnea, Obstructive
Bayer Identifier:
19038
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Obstructive Sleep Apnea (OSA) treated with a Potassium Channel Inhibitor
Trial purpose
The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
34Trial Dates
August 2018 - September 2019Phase
Phase 2Could I Receive a placebo
YesProducts
BAY2253651Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Oxford University Hospitals | Oxford, OX9 3DU, United Kingdom |
Withdrawn | Freeman Hospital | Newcastle Upon Tyne, NE7 7DN, United Kingdom |
Completed | University Hospital Zürich | Zürich, 8091, Switzerland |
Primary Outcome
- Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%date_rangeTime Frame:2 days
Secondary Outcome
- Incidence of treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 7 days
- Severity of treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 7 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3