Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension
1 other identifier
interventional
21
1 country
3
Brief Summary
This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
July 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedAugust 21, 2023
March 1, 2023
1.5 years
May 20, 2021
August 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine
10 days of treatment per crossover arm
Secondary Outcomes (1)
Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
10 days of treatment per crossover arm
Study Arms (2)
AD113
EXPERIMENTALTwo oral capsules administered before bed
Atomoxetine
EXPERIMENTALTwo oral capsules administered before bed
Interventions
Eligibility Criteria
You may qualify if:
- Between 25 to 65 years of age, inclusive, at the Screening Visit.
- AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation)
- History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg
You may not qualify if:
- History of narcolepsy.
- Clinically significant craniofacial malformation.
- Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
- CPAP should not be used for at least 2 weeks prior to first study PSG
- History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apnimedlead
Study Sites (3)
PCCAB
Towson, Maryland, 21286, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Bogan Sleep Consultants
Columbia, South Carolina, 29201, United States
Related Publications (1)
Schwartz AR, Herpel L, Bogan R, Corser B, Pho H, Taranto-Montemurro L. Atomoxetine and spironolactone combine to reduce obstructive sleep apnea severity and blood pressure in hypertensive patients. Sleep Breath. 2024 Dec;28(6):2571-2580. doi: 10.1007/s11325-024-03113-1. Epub 2024 Sep 21.
PMID: 39305436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 28, 2021
Study Start
July 31, 2021
Primary Completion
January 31, 2023
Study Completion
May 31, 2023
Last Updated
August 21, 2023
Record last verified: 2023-03