A Dose Titration of Droxidopa in Patients With Spinal Cord Injury
Public ClinicalTrials.gov record NCT01354158. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose Response Trial of Droxidopa to Treat Hypotension in Persons With SCI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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?
Study identification
- NCT ID
- NCT01354158
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2011
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Jul 29, 2013
2011 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01354158, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2013 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01354158 live on ClinicalTrials.gov.