Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    15
  • sponsor
    Apnimed
Updated on 28 June 2021
hypertension

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

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 will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Details
Condition Vascular Diseases, Hypertension, Obstructive sleep apnea, Elevated Blood Pressure, obstructive sleep apnoea, obstructive sleep apnea syndrome, high blood pressure, arterial hypertension
Treatment atomoxetine, AD113
Clinical Study IdentifierNCT04905979
SponsorApnimed
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 controlled with 1 - 2 medications

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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