Trial Outcomes & Findings for Drug Combination on Exercise Performance at High Altitude (NCT NCT01902758)
NCT ID: NCT01902758
Last Updated: 2016-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
28 participants
Primary outcome timeframe
after arriving at high altitude (within 1 hour)
Results posted on
2016-02-26
Participant Flow
Participant milestones
| Measure |
Ambrisentan and Theophylline
ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Combination on Exercise Performance at High Altitude
Baseline characteristics by cohort
| Measure |
Ambrisentan and Theophylline
n=14 Participants
ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline
|
Placebo
n=14 Participants
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
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 2 • n=5 Participants
|
23 years
STANDARD_DEVIATION 2 • n=7 Participants
|
23 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after arriving at high altitude (within 1 hour)Outcome measures
| Measure |
Ambrisentan and Theophylline
n=14 Participants
ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline
|
Placebo
n=14 Participants
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
|
|---|---|---|
|
Time (Minutes) to Complete 2 Miles on a Treadmill
|
1544 seconds
Standard Deviation 109
|
1540 seconds
Standard Deviation 158
|
Adverse Events
Ambrisentan and Theophylline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of the Montana Center for Work Physiology and Exercise Metabolism
University of Montana
Phone: 406-243-2117
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place