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NCT05300477 · ClinicalTrials.gov registry record · Phase 4
Pharmacological Countermeasures for High Altitude
A Phase 4 study of Hypobaric Hypoxia, sponsored by United States Army Research Institute of Environmental Medicine.
- Active
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05300477: Active Phase 4 study of Hypobaric Hypoxia, sponsored by United States Army Research Institute of Environmental Medicine.
NCT05300477 is a Phase 4 study of Hypobaric Hypoxia that is active but no longer recruiting, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05300477, a Phase 4 study of Hypobaric Hypoxia, is active but no longer recruiting, sponsored by United States Army Research Institute of Environmental Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this randomized, double-blind study is to determine whether erythropoietin (Procrit) and acetazolamide: 1) mitigates altitude-induced decrements in performance at moderate altitude (3,000 m) and 2) mitigates altitude-induced decrements in performance and reduce acute mountain sickness during prolonged exposure to high altitude (4,300 m; 15 days). Volunteers will complete 5 study phases: Phase 1) sea level baseline testing and a moderate altitude exposure; Phase 2) 4 week study intervention - randomly assigned to receive erythropoietin or placebo); Phase 3) 3 1/2 days of acetazolamide and a moderate altitude exposure; Phase 4) high altitude acclimatization - 15 days at Pikes Peak; and Phase 5) two week deacclimatization. Test battery include VO2peak, 3.2 km treadmill time trial, measures of gas exchange and ventilation during rest and exercise, and blood collection.
Primary Outcome
Time to complete self-paced 3.2 km treadmill time trial (min:sec)
Conditions Studied
Interventions
- DRUG Acetazolamide
- DRUG Erythropoietin
Study Locations (1)
Massachusetts
- USARIEM - Natick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 4 |
What the registry record for NCT05300477 still lists
NCT05300477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Hypobaric Hypoxia appearing as the primary indexed condition, and to 2 interventions - of which Acetazolamide is the first listed.
NCT05300477 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05300477 about?
NCT05300477 is a clinical study titled "Pharmacological Countermeasures for High Altitude". The aim of this randomized, double-blind study is to determine whether erythropoietin (Procrit) and acetazolamide: 1) mitigates altitude-induced decrements in performance at moderate altitude (3,000 m) and 2) mitigates altitude-induced decrements in performance and reduce acute mountain sickness dur...
What is the current status of trial NCT05300477?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2022-05-27. Estimated completion is 2025-09-30.
What conditions does trial NCT05300477 study?
This clinical trial studies the following conditions: Hypobaric Hypoxia.
What interventions are being tested in trial NCT05300477?
The interventions under investigation include: Acetazolamide (DRUG), Erythropoietin (DRUG).
Who is sponsoring clinical trial NCT05300477?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05300477 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05300477's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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