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| ID | Type | Description | Link |
|---|---|---|---|
| N66001-10-C-2134 | Other Grant/Funding Number | DARPA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ambrisentan and theophylline | Experimental | ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days |
|
| placebo | Placebo Comparator | matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ambrisentan and theophylline | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Minutes) to Complete 2 Miles on a Treadmill | after arriving at high altitude (within 1 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana Center for Work Physiology and Exercise Metabolism | Missoula | Montana | 59812 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambrisentan and Theophylline | ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days ambrisentan and theophylline |
| FG001 | Placebo | matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group placebo: placebo for comparison group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambrisentan and Theophylline | ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days ambrisentan and theophylline |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time (Minutes) to Complete 2 Miles on a Treadmill | Posted | Mean | Standard Deviation | seconds | after arriving at high altitude (within 1 hour) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ambrisentan and Theophylline | ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days ambrisentan and theophylline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of the Montana Center for Work Physiology and Exercise Metabolism | University of Montana | 406-243-2117 | brent.ruby@mso.umt.edu |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C467894 | ambrisentan |
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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placebo for comparison group |
|
matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Placebo | matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group placebo: placebo for comparison group | 0 | 14 | 0 | 14 |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |