Phase 3
N=28
Drug Combination on Exercise Performance at High Altitude
Acute Mountain Sickness
Bottom Line
View on ClinicalTrials.gov: NCT01902758 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Time (Minutes) to Complete 2 Miles on a Treadmill — 1544; 1540 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ambrisentan and theophylline (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Montana
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (Minutes) to Complete 2 Miles on a Treadmill |
1544; 1540 | — |
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.
Eligibility Criteria
Inclusion Criteria
- healthy males
Exclusion Criteria
- VO2max below 45ml/kg/min
- currently taking any medication
Data sourced from ClinicalTrials.gov (NCT01902758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.