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Drug Combination on Exercise Performance at High Altitude

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ClinicalTrials.gov Identifier: NCT01902758
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : January 25, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Brent Ruby, University of Montana

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.

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: ambrisentan and theophylline Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
Study Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


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




Primary Outcome Measures :
  1. Time (Minutes) to Complete 2 Miles on a Treadmill [ Time Frame: after arriving at high altitude (within 1 hour) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902758


Locations
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United States, Montana
Montana Center for Work Physiology and Exercise Metabolism
Missoula, Montana, United States, 59812
Sponsors and Collaborators
University of Montana

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Responsible Party: Brent Ruby, Director of the Montana Center for Work Physiology and Exercise Metabolism, University of Montana
ClinicalTrials.gov Identifier: NCT01902758     History of Changes
Other Study ID Numbers: UM82-13
N66001-10-C-2134 ( Other Grant/Funding Number: DARPA )
First Posted: July 18, 2013    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016

Keywords provided by Brent Ruby, University of Montana:
exercise performance

Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Ambrisentan
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antihypertensive Agents