Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aminophylline · 1 trial · 1 indication
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...
Aminophylline is being studied for use in Acute Mountain Sickness and Fatigue. It is an investigational small molecule being developed by United Therapeutics Corporation. The drug is currently in Phase 1 clinical development, and it has not been approved by the FDA.
Aminophylline is being developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is conducting clinical research on this small molecule for the treatment of Acute Mountain Sickness and Fatigue.
Aminophylline is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for Acute Mountain Sickness and Fatigue, and it is not yet available as a marketed therapy.
Aminophylline has one completed clinical trial, NCT01794078, titled "A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude." This Phase 1 trial enrolled 92 participants in the United States.
Aminophylline is a distinct drug entity and is not known to be the same as any other drug. It is being studied as a standalone small molecule for Acute Mountain Sickness and Fatigue, and no alternative names have been associated with it in clinical development.