Trial · NCT01132326
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
NCT01132326, Phase 3, Completed, Chelsea Therapeutics; results first posted 2014-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304). Trials, record NCT01132326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01132326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
- NCT number
- NCT01132326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 350 participants, actual
- Lead sponsor
- Chelsea Therapeutics
- Conditions
- Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
- Interventions
- Droxidopa
- First posted
- 2010-05-28
- Last updated
- 2024-02-09
- Results first posted
- 2014-04-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Treatment-emergent Adverse Events | up to 2 years | Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study |
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 | Patients With Treatment-emergent Adverse Events | up to 2 years | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Patients With Treatment-emergent Adverse Events | Droxidopa | 263 | 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 | Droxidopa | 350 | |
| Overall Study | COMPLETED | Droxidopa | 132 | |
| Overall Study | NOT COMPLETED | Droxidopa | 218 |
Source ClinicalTrials.gov
Adverse events112
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 | Headache | Nervous system disorders | Droxidopa | 42 | 350 | 59 |
| other | Syncope | Nervous system disorders | Droxidopa | 35 | 350 | 44 |
| other | Dizziness | Nervous system disorders | Droxidopa | 34 | 350 | 54 |
| other | Fall | Injury, poisoning and procedural complications | Droxidopa | 80 | 350 | 157 |
| other | Contusion | Injury, poisoning and procedural complications | Droxidopa | 18 | 350 | 40 |
| other | Urinary tract infection | Infections and infestations | Droxidopa | 45 | 350 | 107 |
| other | Nausea | Gastrointestinal disorders | Droxidopa | 23 | 350 | 27 |
| other | Fatigue | General disorders | Droxidopa | 28 | 350 | 30 |
| other | Asthenia | General disorders | Droxidopa | 20 | 350 | 21 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Droxidopa | 19 | 350 | 24 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Droxidopa | ||
| Total, other adverse events | Droxidopa | 178 | 350 |
| Total, serious adverse events | Droxidopa | 83 | 350 |
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/NCT01132326
GET https://conductscience.org/api/trials/v1/NCT01132326/events?page=2