Back to resultsTreatment of Orthostatic Hypotension
Primary Purpose
Autonomic Nervous System Diseases, Orthostatic Hypotension, Dopamine Beta-Hydroxylase Deficiency
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Droxidopa Oral Product
Sponsored by
About this trial
This is an interventional treatment trial for Autonomic Nervous System Diseases focused on measuring autonomic nervous system diseases, blood pressure, congenital, orthostasis, catecholamines
Eligibility Criteria
Inclusion Criteria:
- patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
- non-smokers
- drug-free
- able to give informed consent
- free of pulmonary, renal, hematopoietic, hepatic and cardiac disease
Exclusion Criteria:
- medications affecting the autonomic nervous system
- any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
- anemia (Hct < 30)
- women of childbearing age who are pregnant or nursing
- smokers
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Droxidopa
Arm Description
Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were administered Droxidopa doses of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg or 300 mg up to three times daily. Supine and upright blood pressures were subsequently measured 60 to 240 minutes post-dose.
Outcomes
Primary Outcome Measures
Change in Systolic Blood Pressure With Standing
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00581477
First Posted
December 22, 2007
Last Updated
February 28, 2022
Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00581477
Brief Title
Treatment of Orthostatic Hypotension
Official Title
Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
1. enrollment slower than anticipated; 2. FDA approval of droxidopa so no longer need to treat patients on research basis; 3. personnel who were primarily responsible for the study are no longer at Vanderbilt.
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.
Detailed Description
We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases, Orthostatic Hypotension, Dopamine Beta-Hydroxylase Deficiency, Orthostatic Intolerance
Keywords
autonomic nervous system diseases, blood pressure, congenital, orthostasis, catecholamines
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Although the study was designed as a potential trial of multiple medications, plus placebo, in actuality it served as a means of safely determining the optimal dose of Droxidopa for our patients with Dopamine beta-Hydroxylase Deficiency to take at home. Before each dose of Droxidopa, blood pressure and heart rate were measured for 30 minutes. At 60 or 120 minutes after dosing, blood pressure was also measured after 5 minutes of lying down and 5 minutes of sitting or standing. These measurements were used to calculate the orthostatic change in systolic blood pressure, the primary outcome.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Droxidopa
Arm Type
Experimental
Arm Description
Patients with known or suspected Dopamine beta-Hydroxylase Deficiency were administered Droxidopa doses of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg or 300 mg up to three times daily. Supine and upright blood pressures were subsequently measured 60 to 240 minutes post-dose.
Intervention Type
Drug
Intervention Name(s)
Droxidopa Oral Product
Other Intervention Name(s)
L-DOPS
Intervention Description
Droxidopa administered in increasing dosages up to 300 mg
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure With Standing
Description
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.
Time Frame
Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses
non-smokers
drug-free
able to give informed consent
free of pulmonary, renal, hematopoietic, hepatic and cardiac disease
Exclusion Criteria:
medications affecting the autonomic nervous system
any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
anemia (Hct < 30)
women of childbearing age who are pregnant or nursing
smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Robertson, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Orthostatic Hypotension
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