At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 28 enrolled
Drug / intervention
ambrisentan and theophylline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
In Brief
A Phase 3 clinical trial evaluating ambrisentan and theophylline and placebo for Acute Mountain Sickness. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Mountain Sickness
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionAug 2013
TodayJul 2026
First PostedJul 18, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 13.0 years ago
Interventions
ambrisentan and theophyllinedrug
placebodrug
placebo for comparison group