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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: Clinical Trial Phase 4 study, sponsored by Shire.
NCT00046163 is a Phase 4 study that was terminated before completion, run by Shire. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Standing time was assessed after the participant and clinician questionnaires and blood pressure measurements are completed.
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 |
Why NCT00046163 stopped before completion
NCT00046163 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which midodrine hydrochloride (ProAmatine®) is the first listed.
NCT00046163 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00046163's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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