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NCT01285908 · ClinicalTrials.gov registry record · Phase 1
Intravenous Norepinephrine for Orthostatic Hypotension
A Phase 1 study of Orthostatic Hypertension, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01285908: Completed Phase 1 study of Orthostatic Hypertension, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01285908 is a Phase 1 study of Orthostatic Hypertension that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285908, a Phase 1 study of Orthostatic Hypertension, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pressure in check. In orthostatic hypotension, the nervous system does not release enough norepinephrine when a person stands up, which can cause fainting or falling. Researchers are interested in determining whether norepinephrine given as a drug by vein can help maintain blood pressure during changes in body position. Objectives: \- To determine whether intravenous norepinephrine can maintain blood pressure in people with orthostatic hypotension. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension related to Parkinson's disease or pure autonomic failure. Design: * This study will require a 2-day inpatient admission to the NIH Clinical Center. The first day will involve laboratory evaluation and the second day will involve testing with norepinephrine. The second day requires an overnight stay. * Participants will be screened with a medical history and physical examination, blood samples, and an electrocardiogram or echocardiogram. * Participants who are on medications may be asked to taper or discontinue one or more medications for the purposes of this study. Participants may not take aspirin or any drugs that slow blood clotting for 7 days before study participation. * Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure. Body temperature and breathing will also be monitored. * Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt table test. Initial blood pressure readings will be taken, and an intravenous line will be placed. Participants will then receive norepine
Primary Outcome
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.
Conditions Studied
Interventions
- DRUG Intravenous Norepinephrine Infusion
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01285908 record still lists
NCT01285908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Orthostatic Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Intravenous Norepinephrine Infusion is the first listed.
NCT01285908 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01285908 about?
NCT01285908 is a clinical study titled "Intravenous Norepinephrine for Orthostatic Hypotension". Background: \- Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pres...
What is the current status of trial NCT01285908?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-01. Estimated completion is 2012-09.
What conditions does trial NCT01285908 study?
This clinical trial studies the following conditions: Orthostatic Hypertension.
What interventions are being tested in trial NCT01285908?
The interventions under investigation include: Intravenous Norepinephrine Infusion (DRUG).
Who is sponsoring clinical trial NCT01285908?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01285908 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01285908's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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