Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 140 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Midodrine Hydrochloride

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 1997-12-01
Est. Completion 1999-11-24
Phase Phase 4

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00046475

The ClinicalTrials.gov registry entry for NCT00046475 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 140 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 is the first listed.

NCT00046475 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.