Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

August 17, 2023 updated by: Apnimed

Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21286
        • PCCAB
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Intrepid Research
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Bogan Sleep Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD113
Two oral capsules administered before bed
Drug: AD113
Two oral capsules administered before bed
Experimental: Atomoxetine
Two oral capsules administered before bed
Drug: Atomoxetine
Two oral capsules administered before bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days of treatment per crossover arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days of treatment per crossover arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnimed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APX-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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