Drug Combination on Exercise Performance at High Altitude

January 28, 2016 updated by: Brent Ruby, University of Montana

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

  • VO2max below 45ml/kg/min
  • currently taking any medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ambrisentan and theophylline
ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
Drug: ambrisentan and theophylline
Placebo Comparator: placebo
matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
Drug: placebo
placebo for comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time (Minutes) to Complete 2 Miles on a Treadmill
Time Frame: after arriving at high altitude (within 1 hour)
after arriving at high altitude (within 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Montana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM82-13
  • N66001-10-C-2134 (Other Grant/Funding Number: DARPA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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