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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00046163 |
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.
Condition | Intervention | Phase |
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Hypotension, Orthostatic |
Drug: midodrine hydrochloride (ProAmatine®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Multi-Center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled Study to Assess the Clinical Benefit of Three Doses of Midodrine Hydrochloride (ProAmatine®) in Subjects With Neurogenic Orthostatic Hypotension |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Suncoast Neuroscience Associates, Inc. | |
St. Petersburg, Florida, United States | |
United States, Pennsylvania | |
Neurological Associates of Delaware Valley | |
Upland, Pennsylvania, United States | |
United States, Texas | |
Diabetes & Glandular Disease Research Associates, PA, | |
San Antonio, Texas, United States |
Study ID Numbers: | SPD 426-403 |
Study First Received: | September 20, 2002 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00046163 |
Health Authority: | United States: Food and Drug Administration |
Neurology Cardiology |
Multiple system atrophy Hypotension Shy-Drager Syndrome Multiple system atrophy (MSA) with orthostatic hypotension Hypotension, Orthostatic Ganglion Cysts Basal Ganglia Diseases Vascular Diseases Central Nervous System Diseases |
Brain Diseases Neurodegenerative Diseases Postural hypotension Autonomic Nervous System Diseases Multiple System Atrophy Movement Disorders Midodrine Atrophy |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases Peripheral Nervous System Agents |