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.
Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
Sponsor study identifier
Secondary identifiers
NIH
interventional
8
1 country
1
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2020
Actual (reported)Study Completion
December 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 22, 2007
Actual (reported)December 27, 2007
Actual (reported)December 2020
Actual (reported)December 2020
Actual (reported)March 2, 2022
Actual (reported)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.
Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.
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.
Droxidopa administered in increasing dosages up to 300 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vanderbilt University
Nashville, Tennessee, 37232, United States
David Robertson, MD
Vanderbilt University
8 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2007
First Posted
Treatment of Post-SCI Hypotension
Contact the study team to confirm eligibility.
December 27, 2007
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2020
Actual (reported)Study Completion
December 2020
Actual (reported)Last Updated
March 2, 2022
Results First Posted
March 2, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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