drugset / Trial / NCT00046475

A Study for Patients With Neurogenic Orthostatic Hypotension

NCT00046475

Phase 4 Completed 140 enrolled Shire
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
1997-12-01
Primary completion
1999-11-24
Completion
1999-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Midodrine Small molecule