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NCT00046475 · ClinicalTrials.gov registry record · Phase 4
A Study for Patients With Neurogenic Orthostatic Hypotension
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
NCT00046475: Completed Phase 4 study, sponsored by Shire.
NCT00046475 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046475, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 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 benefit of 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 and standing positions will be measured at each visit.
Primary Outcome
Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.
Interventions
- DRUG Midodrine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 1997-12-01 |
| Est. Completion | 1999-11-24 |
| Phase | Phase 4 |
What the finished NCT00046475 record still lists
NCT00046475 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Midodrine Hydrochloride is the first listed.
NCT00046475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00046475 about?
NCT00046475 is a clinical study titled "A Study for Patients 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 NCT00046475?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 1997-12-01. Estimated completion is 1999-11-24.
What interventions are being tested in trial NCT00046475?
The interventions under investigation include: Midodrine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00046475?
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 NCT00046475's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 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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