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Drug Combination on Exercise Performance at High Altitude

Information source: University of Montana
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Mountain Sickness

Intervention: ambrisentan and theophylline (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Montana

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.

Clinical Details

Official title: Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Primary outcome: Time (minutes) to complete 2 miles on a treadmill

Secondary outcome: Time (minutes) to complete 2 miles on a treadmill

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- healthy males

Exclusion Criteria:

- VO2max below 45ml/kg/min

- currently taking any medication

Locations and Contacts

Montana Center for Work Physiology and Exercise Metabolism, Missoula, Montana 59812, United States
Additional Information

Starting date: August 2013
Last updated: February 26, 2014

Page last updated: August 23, 2015

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