Status:
COMPLETED
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Lead Sponsor:
Apnimed
Conditions:
Obstructive Sleep Apnea
Hypertension
Eligibility:
All Genders
25-65 years
Phase:
PHASE2
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
Detailed Description
The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04905979
Start Date
July 31 2021
End Date
May 31 2023
Last Update
August 21 2023
Active Locations (3)
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1
PCCAB
Towson, Maryland, United States, 21286
2
Intrepid Research
Cincinnati, Ohio, United States, 45245
3
Bogan Sleep Consultants
Columbia, South Carolina, United States, 29201