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NCT02463357 · ClinicalTrials.gov registry record · Phase 4

Three New Ideas to Protect Special Forces From the Stress of High Altitude

A Phase 4 study of Mountain Sickness, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
148
Enrollment target
1
Study location

NCT02463357 is a Phase 4 study of Mountain Sickness that has completed, run by University of Colorado, Denver. The registered enrollment target is 148 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT02463357, a Phase 4 study of Mountain Sickness, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
148 participants
Enrollment target
1
Study location

Study Summary

Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. Therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of AMS and improve physical and cognitive performance at high altitude. The investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Metformin
  • DIETARY_SUPPLEMENT Quercetin
  • DRUG Nifedipine extended release
  • DRUG Methazolamide

Study Locations (1)

Michigan

  • Alma College - Alma

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2015-08
Est. Completion 2016-09
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT02463357

The ClinicalTrials.gov registry entry for NCT02463357 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mountain Sickness appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT02463357 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT02463357 about?

NCT02463357 is a clinical study titled "Three New Ideas to Protect Special Forces From the Stress of High Altitude". Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by head...

What is the current status of trial NCT02463357?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 148 participants. The study started on 2015-08. Estimated completion is 2016-09.

What conditions does trial NCT02463357 study?

This clinical trial studies the following conditions: Mountain Sickness.

What interventions are being tested in trial NCT02463357?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Quercetin (DIETARY_SUPPLEMENT), Nifedipine extended release (DRUG), Methazolamide (DRUG).

Who is sponsoring clinical trial NCT02463357?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02463357 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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