Trial · NCT04095793
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
NCT04095793, Phase 3, Terminated, Theravance Biopharma; results first posted 2022-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure. Trials, record NCT04095793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04095793
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
- NCT number
- NCT04095793
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- Theravance Biopharma
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- Interventions
- ampreloxetine
- First posted
- 2019-09-19
- Last updated
- 2022-11-30
- Other registries' IDs
- eudract:2019-002425-30
- Results first posted
- 2022-11-30
- Limitations and caveats
- Because the study was terminated early by the Sponsor, the latest scheduled study visit completed by any participant was at Week 98.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to a maximum of 749 days | 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, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to a maximum of 749 days | The safety set was defined as all enrolled participants who received at least 1 dose of ampreloxetine in the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Ampreloxetine | 61 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ampreloxetine | 110 | |
| Overall Study | COMPLETED | Ampreloxetine | 0 | |
| Overall Study | NOT COMPLETED | Ampreloxetine | 110 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Ampreloxetine | 8 | 110 | |
| other | Headache | Nervous system disorders | Ampreloxetine | 6 | 110 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ampreloxetine | 5 | 110 | |
| other | Benign prostatic hyperplasia | Reproductive system and breast disorders | Ampreloxetine | 4 | 110 | |
| other | Diarrhoea | Gastrointestinal disorders | Ampreloxetine | 4 | 110 | |
| other | Fatigue | General disorders | Ampreloxetine | 4 | 110 | |
| serious | Orthostatic hypotension | Vascular disorders | Ampreloxetine | 1 | 110 | 1 |
| serious | Cystitis | Infections and infestations | Ampreloxetine | 1 | 110 | 1 |
| serious | Decubitus ulcer | Skin and subcutaneous tissue disorders | Ampreloxetine | 1 | 110 | 1 |
| serious | Pneumonia | Infections and infestations | Ampreloxetine | 1 | 110 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ampreloxetine | 1 | 110 |
| Total, other adverse events | Ampreloxetine | 24 | 110 |
| Total, serious adverse events | Ampreloxetine | 14 | 110 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04095793
GET https://conductscience.org/api/trials/v1/NCT04095793/events?page=2