NCT00046475

A Study for Patients With Neurogenic Orthostatic Hypotension

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients With Neurogenic Orthostatic Hypotension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension, Orthostatic

Interventions

Type	Name	Description
DRUG	Midodrine Hydrochloride

Timeline

• Start date: 1997-12-01
• Primary completion: 1999-11-24
• Completion: 1999-11-24
• First posted: 2002-10-02
• Last updated: 2021-06-11
• Results posted: 2015-05-12

Locations

15 sites across 1 country: United States