Drug Combination on Exercise Performance at High Altitude
Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
January 25, 2016
CompletedFebruary 26, 2016
January 1, 2016
Same day
July 11, 2013
December 16, 2015
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time (Minutes) to Complete 2 Miles on a Treadmill
after arriving at high altitude (within 1 hour)
Study Arms (2)
ambrisentan and theophylline
EXPERIMENTALambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
placebo
PLACEBO COMPARATORmatched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
Interventions
Eligibility Criteria
You may qualify if:
- healthy males
You may not qualify if:
- VO2max below 45ml/kg/min
- currently taking any medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montana Center for Work Physiology and Exercise Metabolism
Missoula, Montana, 59812, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of the Montana Center for Work Physiology and Exercise Metabolism
- Organization
- University of Montana
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Montana Center for Work Physiology and Exercise Metabolism
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 18, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
February 26, 2016
Results First Posted
January 25, 2016
Record last verified: 2016-01