Drug Combination on Exercise Performance at High Altitude

NCT ID: NCT01902758

Last Updated: 2016-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Mountain Sickness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ambrisentan and theophylline

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

Group Type EXPERIMENTAL

ambrisentan and theophylline

Intervention Type DRUG

placebo

matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo for comparison group

Interventions

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ambrisentan and theophylline

Intervention Type DRUG

placebo

placebo for comparison group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy males

Exclusion Criteria

* VO2max below 45ml/kg/min
* currently taking any medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Montana

OTHER

Sponsor Role lead

Responsible Party

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Brent Ruby

Director of the Montana Center for Work Physiology and Exercise Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montana Center for Work Physiology and Exercise Metabolism

Missoula, Montana, United States

Site Status

Countries

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United States

Other Identifiers

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N66001-10-C-2134

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UM82-13

Identifier Type: -

Identifier Source: org_study_id

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