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VicTor: AD816 vs Viloxazine in Obstructive Sleep Apnea
NCT05793684Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2023
- Primary completion
- Nov 2023
- Countries
- 1
- Sponsor
- Apnimed, Inc.
- Modality
- Small Molecules
- Conditions
- obstructive sleep apnea (OSA)
01
Overview
Phase 2, randomised, double-blind trial of trazodone + viloxazine in obstructive sleep apnea (OSA) (6 arms), sponsored by Apnimed, Inc. Primary endpoint: Apnea-Hypopnea Index (4% desaturation) at 14 days. Started Apr 2023; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Sequence ABC
Viloxazine -> AD816 -> Placebo
Sequence ACB
Viloxazine -> Placebo -> AD816
Sequence BAC
AD816 -> Viloxazine -> Placebo
Sequence BCA
AD816 -> Placebo -> Viloxazine
Sequence CAB
Placebo -> Viloxazine -> AD816
Sequence CBA
Placebo -> AD816 -> Viloxazine
03
Who it enrols
Adults 18-75 with Obstructive Sleep Apnea (AHI4 10-45) and BMI 18.5-40.
04
Endpoints
Primary
Apnea-Hypopnea Index (4% desaturation)
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