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Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Primary Purpose

Obstructive Sleep Apnea, Hypertension

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AD113

Atomoxetine

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

PCCAB
Intrepid Research
Bogan Sleep Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AD113

Atomoxetine

Arm Description

Two oral capsules administered before bed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change in AHI for AD113 vs. atomoxetine measured by polysomnography

Full Information

NCT ID

NCT04905979

First Posted

May 20, 2021

Last Updated

August 17, 2023

Sponsor

Apnimed

1. Study Identification

Unique Protocol Identification Number

NCT04905979

Brief Title

Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 31, 2021 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apnimed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AD113

Arm Type

Experimental

Arm Description

Two oral capsules administered before bed

Arm Title

Atomoxetine

Arm Type

Experimental

Arm Description

Two oral capsules administered before bed

Intervention Type

Drug

Intervention Name(s)

AD113

Intervention Description

Two oral capsules administered before bed

Intervention Type

Drug

Intervention Name(s)

Atomoxetine

Intervention Description

Two oral capsules administered before bed

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

10 days of treatment per crossover arm

Secondary Outcome Measure Information:

Title

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

Description

Change in AHI for AD113 vs. atomoxetine measured by polysomnography

Time Frame

10 days of treatment per crossover arm

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

PCCAB

City

Towson

State/Province

Maryland

ZIP/Postal Code

21286

Country

United States

Facility Name

Intrepid Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Bogan Sleep Consultants

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

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