Obstructive Sleep ApneaPhase 2NCT04905979
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
A Phase 2 study testing AD113 and Atomoxetine in people with Obstructive Sleep Apnea and Hypertension, run by Apnimed at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- AD113 and Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2021to 31 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Intrepid Research
Cincinnati, Ohio, 45245
Bogan Sleep Consultants
Columbia, South Carolina, 29201
PCCAB
Towson, Maryland, 21286
About this study
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
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
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Being tested
- AD113, Atomoxetine
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD113Drug
Two oral capsules administered before bed
AtomoxetineDrug
Two oral capsules administered before bed
| Study group | Role | What they receive |
|---|---|---|
| AD113 | Experimental | Two oral capsules administered before bed Receives: Drug: AD113 |
| Atomoxetine | Experimental | Two oral capsules administered before bed Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days of treatment per crossover arm
Secondary outcomes (1)
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
Measured: 10 days of treatment per crossover arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start31 Jul 2021
- Primary completion31 Jan 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905979
- Sponsor's protocol ID
- APX-002
- Status last verified
- Mar 2023
- First submitted
- 20 May 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schwartz AR, Herpel L, Bogan R, Corser B, Pho H, Taranto-Montemurro L. Atomoxetine and spironolactone combine to reduce obstructive sleep apnea severity and blood pressure in hypertensive patients. Sleep Breath. 2024 Dec;28(6):2571-2580. doi: 10.1007/s11325-024-03113-1. Epub 2024 Sep 21.
PubMed 39305436
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04905979
- Acronym / sponsor ID
- APX-002
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ApnimedIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD113 | Experimental | Drug: AD113Two oral capsules administered before bed |
| Atomoxetine | Experimental | Drug: AtomoxetineTwo oral capsules administered before bed |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD113Two oral capsules administered before bed | Drug | AD113 |
| AtomoxetineTwo oral capsules administered before bed | Drug | Atomoxetine |
Primary outcome
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
1 secondary outcome
Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Time frame: 10 days of treatment per crossover arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 39305436Schwartz AR, Herpel L, Bogan R, Corser B, Pho H, Taranto-Montemurro L. Atomoxetine and spironolactone combine to reduce obstructive sleep apnea severity and blood pressure in hypertensive patients. Sleep Breath. 2024 Dec;28(6):2571-2580. doi: 10.1007/s11325-024-03113-1. Epub 2024 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD113 and Atomoxetine in people with Obstructive Sleep Apnea and Hypertension, run by Apnimed at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve) (time frame: 10 days of treatment per crossover arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.