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NCT03845023 · ClinicalTrials.gov registry record · Phase 2
Trial of AD036 in Obstructive Sleep Apnea
A Phase 2 study of Obstructive Sleep Apnea, sponsored by Apnimed.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 12
- Study locations
NCT03845023: Completed Phase 2 study of Obstructive Sleep Apnea, sponsored by Apnimed.
NCT03845023 is a Phase 2 study of Obstructive Sleep Apnea that has completed, run by Apnimed. The registered enrollment target is 140 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (37% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845023, a Phase 2 study of Obstructive Sleep Apnea, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
Primary Outcome
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AD036 Dose 1
- DRUG AD036 Dose 2
- DRUG AD036 Dose 3
Study Locations (12)
California
- Stanford Sleep Medicine - Redwood City
- SDS Clinical Trials, Inc. - Santa Ana
- Santa Monica Clinical Trials - Santa Monica
Arizona
- Pulmonary Associates - Glendale
Arkansas
- Preferred Research Partners, Inc. - Little Rock
Illinois
- Northwestern University - Chicago
Kentucky
- Norton Clinical Research Group - Louisville
Maryland
- The Center for Sleep and Wake Disorders - Chevy Chase
Missouri
- Sleep Medicine & Research Center, St. Luke's Hospital - Chesterfield
New York
- Clinilabs Drug Development Corporation - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2019-03-07 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 2 |
What the finished NCT03845023 record still lists
NCT03845023 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03845023 lists 12 locations in 10 states (California, Arizona, Arkansas).
Frequently Asked Questions
What is clinical trial NCT03845023 about?
NCT03845023 is a clinical study titled "Trial of AD036 in Obstructive Sleep Apnea". This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
What is the current status of trial NCT03845023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2019-03-07. Estimated completion is 2019-10-23.
What conditions does trial NCT03845023 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT03845023?
The interventions under investigation include: Placebo (DRUG), AD036 Dose 1 (DRUG), AD036 Dose 2 (DRUG), AD036 Dose 3 (DRUG).
Who is sponsoring clinical trial NCT03845023?
This trial is sponsored by Apnimed, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03845023 being conducted?
This trial has 12 study locations across Arizona, Arkansas, California, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03845023's enrollment target sits among peer trials
140 51st of 155 higher than 104 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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