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NCT01902758 Clinical Trial

Drug Combination on Exercise Performance at High Altitude

Acute Mountain Sickness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01902758
Other study ID # UM82-13
Secondary ID N66001-10-C-2134
Status Completed
Phase Phase 2/Phase 3
First received July 11, 2013
Last updated January 28, 2016
Start date August 2013
Est. completion date August 2013

Study information
Verified date January 2016
Source University of Montana
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- healthy males

Exclusion Criteria:

- VO2max below 45ml/kg/min

- currently taking any medication

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ambrisentan and theophylline

• placebo
placebo for comparison group

Locations
Country Name City State
United States Montana Center for Work Physiology and Exercise Metabolism Missoula Montana

Sponsors (1)
Lead Sponsor Collaborator
University of Montana

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time (Minutes) to Complete 2 Miles on a Treadmill after arriving at high altitude (within 1 hour) No
See also
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