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NCT04095793 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3 study, sponsored by Theravance Biopharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
NCT04095793: Clinical Trial Phase 3 study, sponsored by Theravance Biopharma.
NCT04095793 is a Phase 3 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04095793, a Phase 3 study, was terminated before completion, sponsored by Theravance Biopharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
Study Summary
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period. Clinically significant abnormalities in physical and neurological examinations, vital signs, rest
Interventions
- DRUG ampreloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2021-11-12 |
| Phase | Phase 3 |
Why NCT04095793 stopped before completion
NCT04095793 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which ampreloxetine is the first listed.
NCT04095793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04095793 about?
NCT04095793 is a clinical study titled "Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure". A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
What is the current status of trial NCT04095793?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2019-09-19. Estimated completion is 2021-11-12.
What interventions are being tested in trial NCT04095793?
The interventions under investigation include: ampreloxetine (DRUG).
Who is sponsoring clinical trial NCT04095793?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04095793's enrollment target sits among peer trials
110 1657th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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