Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00426842 · ClinicalTrials.gov registry record · Phase 2
A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride
A Phase 2 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00426842 is a Phase 2 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT00426842, a Phase 2 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
With upright postures, there is an immediate redistribution of blood to the dependent circulation; venous return and central venous filling pressure are reduced, resulting in diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the baroreceptor reflex, which is mediated via the central nervous system to increase peripheral sympathetic vasomotor tone, restoring blood pressure and cardiac output within seconds-to-minutes of the assumption of the upright position. Following SCI, individuals often experience the inability to adjust to postural changes due to disruption of central command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways; consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue. OH is a well-documented phenomenon, which is characterized by a fall in systolic blood pressure of \>20 mmHg or diastolic BP of \> 10 mmHg within 3 minutes of assumption of an upright posture. As a consequence of OH, many individuals experience symptoms of cerebral hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea, ringing in the ears, cognitive impairment and heart palpitations. Although several investigators have reported increased prevalence of OH during the acute phase of spinal cord injury (SCI), individuals with chronic injury also experience significant falls in blood pressure with seated upright postures. This investigation will examine the effects of an alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure, cerebral blood flow and cerebral oxygenation compared to placebo administration in persons with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour observation study. This is the first study to determine the dose response and efficacy of midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in the SCI population.
Interventions
- DRUG Midodrine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00426842
The ClinicalTrials.gov registry entry for NCT00426842 describes a study currently listed as completed, categorized as Phase 2. 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 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 1 intervention - of which Midodrine Hydrochloride is the first listed.
NCT00426842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00426842 about?
NCT00426842 is a clinical study titled "A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride". With upright postures, there is an immediate redistribution of blood to the dependent circulation; venous return and central venous filling pressure are reduced, resulting in diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the baroreceptor reflex, which is me...
What is the current status of trial NCT00426842?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-01. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00426842?
The interventions under investigation include: Midodrine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00426842?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.