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NCT01354158 · ClinicalTrials.gov registry record · Phase 1
A Dose Titration of Droxidopa in Patients With Spinal Cord Injury
A Phase 1 study, sponsored by Bronx VA Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01354158 is a Phase 1 study that has completed, run by Bronx VA Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT01354158, a Phase 1 study, has completed, sponsored by Bronx VA Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The investigators seek to determine the efficacy, duration of action and safety of escalating dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and catecholamines during upright seated posture. Primary Question: 1\. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and 105±5 mmHg in women? * When does the defined increase in SBP occur after oral ingestion of droxidopa? * How long does this dose of droxidopa sustain SBP at these levels? * What are the vital signs and the subjective symptomology following droxidopa administration? Secondary Question: 1\. What is the MFV response to droxidopa administration in hypotensive individuals with SCI? * Does an increase in SBP correspond to an increase in MCA MFV? Tertiary Question: 1\. What is the vasoactive hormone and catecholamine response to droxidopa administration in hypotensive individuals with SCI? * Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive individuals with SCI?
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01354158
The ClinicalTrials.gov registry entry for NCT01354158 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bronx VA Medical Center, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT01354158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01354158 about?
NCT01354158 is a clinical study titled "A Dose Titration of Droxidopa in Patients With Spinal Cord Injury". The investigators seek to determine the efficacy, duration of action and safety of escalating dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and catecholamines during upright seated posture. Primary Question: 1\. What is the lowest dose of droxidopa that ...
What is the current status of trial NCT01354158?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2011-05. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01354158?
The interventions under investigation include: Droxidopa (DRUG).
Who is sponsoring clinical trial NCT01354158?
This trial is sponsored by Bronx VA Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.
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