Title

Drug Combination on Exercise Performance at High Altitude
Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
  • Phase

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Study Participants

    28
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.
Study Started
Aug 31
2013
Primary Completion
Aug 31
2013
Study Completion
Aug 31
2013
Results Posted
Jan 25
2016
Estimate
Last Update
Feb 26
2016
Estimate

Drug ambrisentan and theophylline

Drug placebo

placebo for comparison group

ambrisentan and theophylline Experimental

ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days

placebo Placebo Comparator

matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group

Criteria

Inclusion Criteria:

healthy males

Exclusion Criteria:

VO2max below 45ml/kg/min
currently taking any medication

Summary

Ambrisentan and Theophylline

Placebo

All Events

Event Type Organ System Event Term

Time (Minutes) to Complete 2 Miles on a Treadmill

Ambrisentan and Theophylline

1544.0
seconds (Mean)
Standard Deviation: 109

Placebo

1540.0
seconds (Mean)
Standard Deviation: 158

Total

28
Participants

Age, Continuous

23
years (Mean)
Standard Deviation: 2

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Ambrisentan and Theophylline

Placebo