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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: Completed Phase 4 study of Mountain Sickness, sponsored by University of Colorado, Denver.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Self-reported assessment of AMS symptoms (headache, lightheaded, dizzy, etc.). The 11-item Environmental Symptoms Questionnaire measures Acute Mountain Sickness symptoms (nausea, weakness, lightheadedness, dizziness, headache, etc.). Possible scores range from 0 to 55 (0-5 per item), with higher scores indicating a better outcome.
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
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT02463357 record still lists
NCT02463357 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
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 a single indexed study location in 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.
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 NCT02463357's enrollment target sits among peer trials
148 567th of 2000 higher than 1,432 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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