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NCT03829657 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Clinical Effect Durability 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
- 203
- Enrollment target
NCT03829657: Clinical Trial Phase 3 study, sponsored by Theravance Biopharma.
NCT03829657 is a Phase 3 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 203 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03829657, a Phase 3 study, was terminated before completion, sponsored by Theravance Biopharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
Study Summary
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Primary Outcome
Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's imp
Interventions
- DRUG Placebo
- DRUG ampreloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2021-11-10 |
| Phase | Phase 3 |
Why NCT03829657 stopped before completion
NCT03829657 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03829657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03829657 about?
NCT03829657 is a clinical study titled "Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure". A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
What is the current status of trial NCT03829657?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2019-02-22. Estimated completion is 2021-11-10.
What interventions are being tested in trial NCT03829657?
The interventions under investigation include: Placebo (DRUG), ampreloxetine (DRUG).
Who is sponsoring clinical trial NCT03829657?
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 NCT03829657's enrollment target sits among peer trials
203 1352nd of 2000 higher than 648 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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