Trial · NCT00782340

A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa

NCT00782340, Phase 3, Completed, Chelsea Therapeutics; results first posted 2014-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa. Trials, record NCT00782340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00782340

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa
NCT number: NCT00782340
Status: Completed
Phases: Phase 3
Enrollment: 263 participants, actual
Lead sponsor: Chelsea Therapeutics
Conditions: Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Interventions: Placebo, Droxidopa
First posted: 2008-10-31
Last updated: 2014-05-16
Results first posted: 2014-05-16

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Orthostatic Hypotension Questionnaire Score (OHQ)	7 days	The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. For the change from randomization, negative numbers represent improvement from randomization in OHQ score.
Secondary	Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)	7 days	OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Secondary	Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score	7 days	OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Secondary	Change in Activities Involving Standing a Short Time (OHDAS Item 1)	7 days	OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Secondary	Change in Activities Involving Walking a Short Time (OHDAS Item 3)	7 days	OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Secondary	Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	7 days	OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.
Secondary	Patient-Reported Clinical Global Improvement - Severity Scores	7 days	The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7).
Secondary	Clinician-Reported Clinical Global Improvement - Severity Scores	7 days	The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows; Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7).
Secondary	Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	7 days	Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Orthostatic Hypotension Questionnaire Score (OHQ)	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Change in Activities Involving Standing a Short Time (OHDAS Item 1)	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Change in Activities Involving Walking a Short Time (OHDAS Item 3)	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)	7 days	Missing data are imputed using the last observation carried forward method.	units on a scale	MEAN
SECONDARY	Patient-Reported Clinical Global Improvement - Severity Scores	7 days		participants	NUMBER
SECONDARY	Clinician-Reported Clinical Global Improvement - Severity Scores	7 days		participants	NUMBER
SECONDARY	Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing	7 days		mmHg	MEAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Orthostatic Hypotension Questionnaire Score (OHQ)	Droxidopa	-1.83	Standard Deviation 2.067	units on a scale
Change in Orthostatic Hypotension Questionnaire Score (OHQ)	Placebo	-0.93	Standard Deviation 1.691	units on a scale
Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)	Droxidopa	-1.98	Standard Deviation 2.310	units on a scale
Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)	Placebo	-0.92	Standard Deviation 1.816	units on a scale
Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score	Droxidopa	-1.68	Standard Deviation 2.125	units on a scale
Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score	Placebo	-0.95	Standard Deviation 1.901	units on a scale
Change in Activities Involving Standing a Short Time (OHDAS Item 1)	Droxidopa	-1.9	Standard Deviation 2.75	units on a scale
Change in Activities Involving Standing a Short Time (OHDAS Item 1)	Placebo	-0.8	Standard Deviation 2.60	units on a scale
Change in Activities Involving Walking a Short Time (OHDAS Item 3)	Droxidopa	-1.7	Standard Deviation 2.55	units on a scale
Change in Activities Involving Walking a Short Time (OHDAS Item 3)	Placebo	-0.6	Standard Deviation 2.37	units on a scale

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open Label Titration	STARTED	Open-Label Titration	263
Open Label Titration	STARTED	Droxidopa	0
Open Label Titration	STARTED	Placebo	0
Open Label Titration	COMPLETED	Open-Label Titration	162
Open Label Titration	COMPLETED	Droxidopa	0
Open Label Titration	COMPLETED	Placebo	0
Open Label Titration	NOT COMPLETED	Open-Label Titration	101
Open Label Titration	NOT COMPLETED	Droxidopa	0
Open Label Titration	NOT COMPLETED	Placebo	0
Randomized Double Blind	STARTED	Open-Label Titration	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events21

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	Open-Label Titration	26	263	34
other	Headache	Nervous system disorders	Droxidopa	6	81	7
other	Headache	Nervous system disorders	Placebo	0	81	0
other	Dizziness	Nervous system disorders	Open-Label Titration	17	263	18
other	Dizziness	Nervous system disorders	Droxidopa	3	81	3
other	Dizziness	Nervous system disorders	Placebo	1	81	1
serious	Nausea	Gastrointestinal disorders	Open-Label Titration	1	263	1
serious	Nausea	Gastrointestinal disorders	Droxidopa	0	81	0
serious	Nausea	Gastrointestinal disorders	Placebo	0	81	0
serious	Vomiting	Gastrointestinal disorders	Open-Label Titration	1	263	1

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Open-Label Titration
Total, all-cause mortality	Droxidopa
Total, all-cause mortality	Placebo
Total, other adverse events	Open-Label Titration	38	263
Total, other adverse events	Droxidopa	9	81
Total, other adverse events	Placebo	1	81
Total, serious adverse events	Open-Label Titration	2	263
Total, serious adverse events	Droxidopa	0	81
Total, serious adverse events	Placebo	0	81

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27538531	DERIVED	PubMed
28494751	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00782340

GET https://conductscience.org/api/trials/v1/NCT00782340/results?page=2

API reference For AI assistants