Trial · NCT00657046

Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension

NCT00657046, Phase 2, Completed, Chelsea Therapeutics; results first posted 2014-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension. Trials, record NCT00657046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00657046

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Trial

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

Title: Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension
NCT number: NCT00657046
Status: Completed
Phases: Phase 2
Enrollment: 85 participants, actual
Lead sponsor: Chelsea Therapeutics
Conditions: Intradialytic Hypotension
Interventions: Droxidopa, Placebo
First posted: 2008-04-14
Last updated: 2014-06-27
Results first posted: 2014-06-27

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change in Average Mean Arterial Blood Pressure During Hemodialysis	6 weeks	Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis. The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula: MAP = (SBP+2\*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean values were averaged across the visits within each period.
Secondary	Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;	6 weeks	Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic blood pressures during hemodialysis. The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).
Secondary	Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;	6 weeks	Evaluate the efficacy of droxidopa as measured by change in the number of hypotension-induced interventions during hemodialysis (HD) sessions between baseline (visits 2-7) and treatment (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).
Secondary	Change in the Hypotension-induced Symptom Severity Score	6 weeks	The hypotension-induced symptom severity score is the sum of a 6 question scale (each rated 0 \[asymptomatic\] to 4 \[severe\]). The questions look at cramps, dizziness, headache, nausea, itchiness, and restless legs syndrome experienced during dialysis. The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).
Secondary	Daily Symptoms Associated With Hemodialysis	6 weeks	The Daily symptoms associated with hemodialysis score is the sum of an 8 question scale (each rated 0 \[asymptomatic\] to 4 \[severe\]). The questions look at fatigability, malaise/weakness, physical disturbance on standing, coldness of limbs, dizziness/lightheadedness, dizziness on standing, general bad feeling, and sleep disorders and asks how each of these items affected the patients daily activities on that day. The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).
Secondary	Change in the Multidimensional Fatigue Inventory (MFI-20)	6 weeks	Fatigue will be measured by the general fatigue domain (items 1, 5, 12 and 16) of MFI-20 and will be summarized by treatment group and treatment period. The scores per item run from 1 to 5. A higher score indicates more fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). This concerns item: 5 and 16. A total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. The value at baseline (visit 7) will be subtracted from the value on treatment (visit 19 or visit 13 if visit 19 is not available).
Other	Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis	6 weeks	Change from baseline (visits 2-7) to end of study (HD visits 14-19) in the drop in systolic blood pressure from pre-hemodialysis to 5 minutes post-hemodialysis. The baseline value was the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value was defined as the average of the values collected at each of the last six treatment visits (visits 14-19).

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 Average Mean Arterial Blood Pressure During Hemodialysis	6 weeks	Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.	mmHg	MEAN
SECONDARY	Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;	6 weeks	Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.	mmHg	MEAN
SECONDARY	Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;	6 weeks	Patients must have completed visits in the visit 14-19 timeframe.	average interventions per session	MEAN
SECONDARY	Change in the Hypotension-induced Symptom Severity Score	6 weeks	Patients must have completed visits in the visit 14-19 time frame.	units on a scale	MEAN
SECONDARY	Daily Symptoms Associated With Hemodialysis	6 weeks	Patients must have completed visits in the visit 14-19 timeframe. Three placebo patients and one droxidopa 600mg patient did not complete their Daily Symptoms Assessments during these visits.	units on a scale	MEAN
SECONDARY	Change in the Multidimensional Fatigue Inventory (MFI-20)	6 weeks	Patients must have completed at least visit 14. Three placebo patients did not complete their Multidimensional Fatigue Inventory during this visit.	units on a scale	MEAN
POST_HOC	Systolic Blood Pressure Difference Between Pre-Hemodialysis and Nadir	6 weeks	Patients must have completed visits in the visit 14-19 timeframe. One droxidopa 400 mg patient did not have the required nadir blood pressure information for visits 14-19 and was excluded from the analysis.	mmHg	MEAN
OTHER_PRE_SPECIFIED	Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis	6 weeks	Patients must have completed visits in the visit 14-19 timeframe.	mmHg	MEAN
POST_HOC	Number Patients With Hypotension Induced Early Termination of Dialysis Procedure	6 weeks	Patients had to have at least one post baseline visit (visit 8 and beyond).	participants	NUMBER

Source ClinicalTrials.gov

Results by group27

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

Outcome	Group	Value	Spread	Units
Change in Average Mean Arterial Blood Pressure During Hemodialysis	Droxidopa 400mg	-0.12	Standard Deviation 10.017	mmHg
Change in Average Mean Arterial Blood Pressure During Hemodialysis	Droxidopa 600mg	1.95	Standard Deviation 6.637	mmHg
Change in Average Mean Arterial Blood Pressure During Hemodialysis	Placebo	1.60	Standard Deviation 9.843	mmHg
Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;	Droxidopa 400mg	3.09	Standard Deviation 16.065	mmHg
Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;	Droxidopa 600mg	2.60	Standard Deviation 9.988	mmHg
Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;	Placebo	-0.35	Standard Deviation 14.695	mmHg
Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;	Droxidopa 400mg	-0.2	Standard Deviation 0.86	average interventions per session
Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;	Droxidopa 600mg	-0.2	Standard Deviation 0.71	average interventions per session
Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;	Placebo	-0.1	Standard Deviation 0.83	average interventions per session
Change in the Hypotension-induced Symptom Severity Score	Droxidopa 400mg	-0.9	Standard Deviation 0.92	units on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Droxidopa 400mg	30
Overall Study	STARTED	Droxidopa 600mg	32
Overall Study	STARTED	Placebo	23
Overall Study	Had at Least 1 Post Baseline Visit	Droxidopa 400mg	30
Overall Study	Had at Least 1 Post Baseline Visit	Droxidopa 600mg	31
Overall Study	Had at Least 1 Post Baseline Visit	Placebo	23
Overall Study	Had Visits up to Visit 18	Droxidopa 400mg	28
Overall Study	Had Visits up to Visit 18	Droxidopa 600mg	30
Overall Study	Had Visits up to Visit 18	Placebo	23
Overall Study	COMPLETED	Droxidopa 400mg	26

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events87

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	Procedural Nausea	Gastrointestinal disorders	Droxidopa 400mg	5	30	6
other	Procedural Nausea	Gastrointestinal disorders	Droxidopa 600mg	6	31	9
other	Procedural Nausea	Gastrointestinal disorders	Placebo	3	23	5
other	Vomiting	Gastrointestinal disorders	Droxidopa 400mg	2	30	3
other	Vomiting	Gastrointestinal disorders	Droxidopa 600mg	1	31	1
other	Vomiting	Gastrointestinal disorders	Placebo	2	23	2
other	Asthenia	General disorders	Droxidopa 400mg	4	30	4
other	Asthenia	General disorders	Droxidopa 600mg	4	31	4
other	Asthenia	General disorders	Placebo	2	23	2
other	Fatigue	General disorders	Droxidopa 400mg	4	30	4

1 to 10 of 87Source ClinicalTrials.gov

See all 87 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Droxidopa 400mg
Total, all-cause mortality	Droxidopa 600mg
Total, all-cause mortality	Placebo
Total, other adverse events	Droxidopa 400mg	20	30
Total, other adverse events	Droxidopa 600mg	18	31
Total, other adverse events	Placebo	8	23
Total, serious adverse events	Droxidopa 400mg	3	30
Total, serious adverse events	Droxidopa 600mg	5	31
Total, serious adverse events	Placebo	6	23

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.

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.

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