Trial Outcomes & Findings for Treatment of Orthostatic Hypotension (NCT NCT00581477)

Last Updated: 2022-03-02

Results Overview

The difference between upright and supine systolic blood pressures (dSBP; upright - supine) was calculated for each patient at 60-240 minutes after each dose of droxidopa. For each post-dose timepoint and study day, the average of up to three blood pressure readings per droxidopa dose was calculated. Dosing is individualized for each patient based upon how well the drug is tolerated and the degree of improvement in orthostatic vital signs and symptoms following drug administration. The dosages administered, as well as the number of timepoints and days, therefore, varied between patients.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.

Results posted on

2022-03-02

Participant Flow

Eight patients with known or suspected dopamine beta-hydroxylase (DBH) deficiency were invited or referred for enrollment in this study.

Although all 8 patients received droxidopa while in the study, data is not included for 2 patients who had previously been treated with this medication.

Participant milestones

Participant milestones
Measure	Patients With Dopamine Beta-Hydroxylase Deficiency Patients with known or suspected dopamine beta-hydroxylase deficiency were treated with droxidopa up to 300 mg three time daily. Supine and upright blood pressures were subsequently measured and the length of time the patients were able to stand was ascertained.
Overall Study STARTED	8
Overall Study Dose Selection Trial With Droxidopa	6
Overall Study Droxidopa 25 mg	6
Overall Study Droxidopa 50 mg	6
Overall Study Droxidopa 100 mg	6
Overall Study Droxidopa 200 mg	6
Overall Study Droxidopa 250 mg	6
Overall Study Droxidopa 300 mg	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Dopamine Beta-Hydroxylase Deficiency Patients with known or suspected dopamine beta-hydroxylase deficiency were treated with droxidopa up to 300 mg three time daily. Supine and upright blood pressures were subsequently measured and the length of time the patients were able to stand was ascertained.
Overall Study Physician Decision	2

Baseline Characteristics

Treatment of Orthostatic Hypotension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Dopamine Beta-hydroxylase Deficiency n=6 Participants Patients with known or suspected dopamine beta-hydroxylase deficiency were treated with droxidopa up to 300 mg three time daily. Supine and upright blood pressures were subsequently measured and the length of time the patients were able to stand was ascertained.
Age, Continuous	19 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.

Population: Data is missing for 2 participants who had previously been treated with Droxidopa. In addition, since dosing was individualized for each patient, only those participants with data available at the specified timepoint were analyzed.