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NCT01794078 · ClinicalTrials.gov registry record · Phase 1
A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude
A Phase 1 study of Acute Mountain Sickness and Fatigue, sponsored by Robert J Noveck, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT01794078 is a Phase 1 study of Acute Mountain Sickness and Fatigue that has completed, run by Robert J Noveck, M.D.. The registered enrollment target is 92 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT01794078, a Phase 1 study of Acute Mountain Sickness and Fatigue, has completed, sponsored by Robert J Noveck, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
Acute exposure of the unacclimatized human body to high altitude leads to health complications, such as loss of exercise performance capacity and fatigue. The investigators have found that the combination of the xanthine drug theophylline and the endothelin receptor antagonist ambrisentan improves the exercise performance capacity of rats under simulated high altitude. In young, healthy human volunteers, this combination of drugs has not increase toxicity over the single compounds under sea-level conditions. The aim of this study is to test whether the combination of theophylline, supplied as its more soluble formulation aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267 meters, under both resting and exercising conditions. The study also aims to test whether this drug combination improves exercise capacity in humans. In this study, human subjects will be randomized to one of four treatment sequences and receive the same study drug(s) throughout all procedures. The study consists of an initial exercise test, followed by two cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study drug at simulated altitude and continually monitored for safety with pharmacodynamic and pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only safe under simulated high altitude, but also improves exercise performance capacity, in comparison with placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Aminophylline 400 mg
- DRUG Ambrisentan 5 mg
Study Locations (2)
North Carolina
- Duke Center for Hyperbaric Medicine - Durham
- Duke Clinical Research Unit (DCRU) - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01794078
The ClinicalTrials.gov registry entry for NCT01794078 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Robert J Noveck, M.D., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Mountain Sickness and Fatigue appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01794078 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01794078 about?
NCT01794078 is a clinical study titled "A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude". Acute exposure of the unacclimatized human body to high altitude leads to health complications, such as loss of exercise performance capacity and fatigue. The investigators have found that the combination of the xanthine drug theophylline and the endothelin receptor antagonist ambrisentan improves t...
What is the current status of trial NCT01794078?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2013-09. Estimated completion is 2014-12.
What conditions does trial NCT01794078 study?
This clinical trial studies the following conditions: Acute Mountain Sickness and Fatigue.
What interventions are being tested in trial NCT01794078?
The interventions under investigation include: Placebo (OTHER), Aminophylline 400 mg (DRUG), Ambrisentan 5 mg (DRUG).
Who is sponsoring clinical trial NCT01794078?
This trial is sponsored by Robert J Noveck, M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01794078 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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