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NCT02307565 · ClinicalTrials.gov registry record · Phase 3
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
A Phase 3 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT02307565 is a Phase 3 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 19 participants.
The verdict
NCT02307565, a Phase 3 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
Following spinal cord injury autonomic regulation of the cardiovascular system is impaired, which results in a variety of measurable abnormalities in blood pressure. Evidence of causality has been documented in the general medical literature with findings of improved cognitive function following acute increases in blood pressure using the anti-hypotensive agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an inverse association between blood pressure and depression suggesting that low blood pressure may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food and Drug Administration to treat low blood pressure in the general population. Midodrine is not approved in the United States to treat low blood pressure in persons with spinal cord injury. Therefore, its use in this study is investigational. The first objective is to characterize the relationship between blood pressure, cerebral blood flow velocity and cognitive function after a single dose of midodrine compared to placebo. Second objective is to determine the long-term safety and efficacy of midodrine administration.
Interventions
- DRUG Placebo
- DRUG Midodrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-03 |
| Est. Completion | 2019-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02307565
The ClinicalTrials.gov registry entry for NCT02307565 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02307565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02307565 about?
NCT02307565 is a clinical study titled "Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury". Following spinal cord injury autonomic regulation of the cardiovascular system is impaired, which results in a variety of measurable abnormalities in blood pressure. Evidence of causality has been documented in the general medical literature with findings of improved cognitive function following acu...
What is the current status of trial NCT02307565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2014-03. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02307565?
The interventions under investigation include: Placebo (DRUG), Midodrine (DRUG).
Who is sponsoring clinical trial NCT02307565?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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