Trial · NCT02784535
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
NCT02784535, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2022-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Norepinephrine Transporter Blockade, Autonomic Failure (NETAF). Trials, record NCT02784535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02784535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
- NCT number
- NCT02784535
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Neurogenic Orthostatic Hypotension
- Interventions
- Atomoxetine, Placebo
- First posted
- 2016-05-27
- Last updated
- 2023-09-13
- Results first posted
- 2022-09-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | week 0 to week 4 | The Orthostatic Hypotension Questionnaire (OHQ) , patient-reported assessment tool consisting of the OH Symptom Assessment (OHSA), OH Daily Activity Scale (OHDAS). The composite score is composed of 10 individual items: 6 items measure specific symptoms , the Orthostatic Hypotension Symptom Assessment (OHSA), and 4 items measure the impact of those symptoms on a patient daily activities, the Orthostatic Hypotension Daily Activity Scale (OHDAS). This scales helps to measure the impact of orthostatic symptoms on daily. Scale is between 0-10: where "0" is minimum Orthostatic symptoms and "10" is the maximum / worse possible severity of the symptoms. All items are scored 0 through 10 (higher scores = more impact) and summed into the respective total scores. The OHSA and OHDAS subscales averaged to compute the OHQ composite score. |
| Secondary | Change in Blood Pressure | Baseline to 4 weeks | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (measured in mm of Hg) , is recorded after 10 mins of standing. The changes SBP and DBP are compared from baseline, post drug (4 weeks) |
| Secondary | Change in Heart Rate (HR) | Baseline and at 4 weeks | HR is compared to baseline after 10 mins of standing. The difference increase in Heart rate from baseline, post drug at 4 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | week 0 to week 4 | Score on a scale | MEAN | |
| SECONDARY | Change in Blood Pressure | Baseline to 4 weeks | mm of Hg | MEAN | |
| SECONDARY | Change in Heart Rate (HR) | Baseline and at 4 weeks | Beats per minute | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Placebo | OHQ composite score at Baseline | 4.61 | Standard Deviation 2.16 | Score on a scale |
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Atomoxetin | OHQ composite score at Baseline | 4.17 | Standard Deviation 2.29 | Score on a scale |
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Placebo | OHQ composite score at 4weeks | 3.35 | Standard Deviation 1.98 | Score on a scale |
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Atomoxetin | OHQ composite score at 4weeks | 3.5 | Standard Deviation 2.25 | Score on a scale |
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Placebo | Difference in OHQ composite score at 4 weeks | -0.58 | Standard Deviation 2.39 | Score on a scale |
| Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score | Atomoxetin | Difference in OHQ composite score at 4 weeks | -0.5 | Standard Deviation 1.58 | Score on a scale |
| Change in Blood Pressure | Placebo | difference increase in SBP; post drug 4 weeks; standing for 10 mins | 3.88 | Standard Deviation 19.83 | mm of Hg |
| Change in Blood Pressure | Atomoxetine | difference increase in SBP; post drug 4 weeks; standing for 10 mins | -2.44 | Standard Deviation 23.54 | mm of Hg |
| Change in Blood Pressure | Placebo | DBP;post drug; standing 10 mins at 4 weeks | -3.06 | Standard Deviation 15.85 | mm of Hg |
| Change in Blood Pressure | Atomoxetine | DBP;post drug; standing 10 mins at 4 weeks | -0.94 | Standard Deviation 15.6 | mm of Hg |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine Then Placebo | 20 | |
| Overall Study | STARTED | Placebo Then Atomoxetine | 20 | |
| Overall Study | COMPLETED | Atomoxetine Then Placebo | 19 | |
| Overall Study | COMPLETED | Placebo Then Atomoxetine | 18 | |
| Overall Study | NOT COMPLETED | Atomoxetine Then Placebo | 1 | |
| Overall Study | NOT COMPLETED | Placebo Then Atomoxetine | 2 |
Source ClinicalTrials.gov
Adverse events39
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 | Dose Optimization Phase | 0 | 48 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 40 | |
| other | Headache | Nervous system disorders | Atomoxetine | 1 | 40 | |
| other | Insomnia | Psychiatric disorders | Dose Optimization Phase | 0 | 48 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 40 | |
| other | Insomnia | Psychiatric disorders | Atomoxetine | 1 | 40 | |
| other | Reflux esophagitis | Gastrointestinal disorders | Dose Optimization Phase | 0 | 48 | |
| other | Reflux esophagitis | Gastrointestinal disorders | Placebo | 1 | 40 | |
| other | Reflux esophagitis | Gastrointestinal disorders | Atomoxetine | 2 | 40 | |
| other | Urinary tract infection | Renal and urinary disorders | Dose Optimization Phase | 0 | 48 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Optimization Phase | 0 | 48 |
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, all-cause mortality | Atomoxetine | 1 | 40 |
| Total, other adverse events | Dose Optimization Phase | 1 | 48 |
| Total, other adverse events | Placebo | 13 | 40 |
| Total, other adverse events | Atomoxetine | 13 | 40 |
| Total, serious adverse events | Dose Optimization Phase | 0 | 48 |
| Total, serious adverse events | Placebo | 1 | 40 |
| Total, serious adverse events | Atomoxetine | 2 | 40 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02784535
GET https://conductscience.org/api/trials/v1/NCT02784535/events?page=2