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Completed

NCT Number: NCT04905979

Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PCCAB, Towson, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or blood pressure at Visit 1 ≥130/80 mmHg

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.

Treatment and study plan

AD113

Drug

Two oral capsules administered before bed

Atomoxetine

Drug

Two oral capsules administered before bed

Primary outcomes

  1. Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)

    Time frame: 10 days of treatment per crossover arm

    Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine

Secondary outcomes

  1. Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)

    Time frame: 10 days of treatment per crossover arm

    Change in AHI for AD113 vs. atomoxetine measured by polysomnography

Sponsors and collaborators

Lead sponsor

Apnimed

Industry

Registry information

Official study title

Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 28, 2021
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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