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Drug Combination on Exercise Performance at High Altitude

Phase 2
Completed
Conditions
Acute Mountain Sickness
Interventions
Registration Number
NCT01902758
Lead Sponsor
University of Montana
Brief Summary

This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
28
Inclusion Criteria
  • healthy males
Exclusion Criteria
  • VO2max below 45ml/kg/min
  • currently taking any medication

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ambrisentan and theophyllineambrisentan and theophyllineambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
placeboplacebomatched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
Primary Outcome Measures
NameTimeMethod
Time (Minutes) to Complete 2 Miles on a Treadmillafter arriving at high altitude (within 1 hour)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Montana Center for Work Physiology and Exercise Metabolism

🇺🇸

Missoula, Montana, United States

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