Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01794078 | A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude | PHASE1 | COMPLETED | 92 | — | — | Sep 1, 2013 | Dec 1, 2014 | Nov 13, 2015 | 2 | United States |
Incidence and severity of Adverse Events, blood pressure, heart rate, ECGs, blood oxygen saturation (pulse oximetry), symptoms related to early acute mountain sickness (AMS)
Incidence and severity of Adverse Events, blood pressure, heart rate, ECGs, blood oxygen saturation (pulse oximetry), symptoms related to acute mountain sickness (AMS)
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Oral placebo, administered as single dose during simulated altitude episodes Cycle 1 and Cycle 2 |
| Aminophylline 400 mg | EXPERIMENTAL | Oral aminophylline 400 mg, administered as single dose during simulated altitude episodes Cycle 1 and Cycle 2 |
| ambrisentan 5 mg | EXPERIMENTAL | Oral ambrisentan 5 mg, administered as single dose during simulated altitude episodes Cycle 1 and Cycle 2 |
| Combined aminophylline 400 mg and ambrisentan 5 mg | EXPERIMENTAL | Oral combined aminophylline 400 mg and ambrisentan 5 mg, administered as single doses during simulated altitude episodes Cycle 1 and Cycle 2 |
| Name | Type | Description |
|---|---|---|
| Aminophylline 400 mg | DRUG | Xanthine derivative |
| Ambrisentan 5 mg | DRUG | Endothelin receptor antagonist |
| Placebo | OTHER | - |
Inclusion Criteria: * Subjects must give written Informed Consent to participate in the study prior to undergoing any screening procedures. The subject will be given a signed and dated copy of the Informed Consent. * Subjects must be healthy non-smoking (for 6 months or greater at commencement of C...