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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: Completed Phase 1 study, sponsored by Bronx VA Medical Center.
NCT01354158 is a Phase 1 study that has completed, run by Bronx VA Medical Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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?
Primary Outcome
4 day titration of Droxidopa (placebo day 1, 100mg day 2, 200mg day 3, 400mg day). Blood pressure will be collected at the arm and finger (photoplethysmography) in 15 minute intervals during the duration of the protocol (approximately six hours). The subject will also wear a 24 hour portable arm blood pressure cuff, to assess the effect of Droxidopa on blood pressure 24 hrs post intervention.
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01354158 record still lists
NCT01354158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT01354158 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354158's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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