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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 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. The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Interventions

  • DRUG Acetazolamide
  • DRUG Erythropoietin

Study Locations (1)

Massachusetts

  • USARIEM - Natick

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2022-05-27
Est. Completion 2025-09-30
Phase Phase 4

What the Registry Record Tells You About NCT05300477

The ClinicalTrials.gov registry entry for NCT05300477 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.