Drug Combination on Exercise Performance at High Altitude

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Brief Title

Drug Combination on Exercise Performance at High Altitude

Official Title

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

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.
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Time (Minutes) to Complete 2 Miles on a Treadmill


Condition

Acute Mountain Sickness

Intervention

ambrisentan and theophylline

Study Arms / Comparison Groups

 ambrisentan and theophylline
Description:  ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

August 2013

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility Criteria

        Inclusion Criteria:

          -  healthy males

        Exclusion Criteria:

          -  VO2max below 45ml/kg/min

          -  currently taking any medication
      

Gender

Male

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01902758

Organization ID

UM82-13

Secondary IDs

N66001-10-C-2134

Responsible Party

Principal Investigator

Study Sponsor

University of Montana


Study Sponsor

, , 


Verification Date

January 2016