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NCT00046163 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension
A Phase 4 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT00046163 is a Phase 4 study that was terminated before completion, run by Shire. The registered enrollment target is 150 participants.
The verdict
NCT00046163, a Phase 4 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study Summary
We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical effect of high dose midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down, sitting and standing positions will be measured. Patients will also complete standing time assessments. They will be asked to remain standing without moving until they feel sufficiently lightheaded, or dizzy, or feel faint so that they would feel more comfortable sitting down.
Interventions
- DRUG midodrine hydrochloride (ProAmatine®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2002-09-05 |
| Est. Completion | 2003-08-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00046163
The ClinicalTrials.gov registry entry for NCT00046163 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which midodrine hydrochloride (ProAmatine®) is the first listed.
NCT00046163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00046163 about?
NCT00046163 is a clinical study titled "A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension". We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonom...
What is the current status of trial NCT00046163?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2002-09-05. Estimated completion is 2003-08-06.
What interventions are being tested in trial NCT00046163?
The interventions under investigation include: midodrine hydrochloride (ProAmatine®) (DRUG).
Who is sponsoring clinical trial NCT00046163?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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