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| Sponsored by: |
Shire Pharmaceutical Development |
|---|---|
| Information provided by: | Shire Pharmaceutical Development |
| ClinicalTrials.gov Identifier: | NCT00046475 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypotension, Orthostatic |
Drug: Midodrine Hydrochloride |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients With Neurogenic Orthostatic Hypotension |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| North Alabama Neuroscience Research | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Florida | |
| Dr. Harry Pepe & Associates, Inc. | |
| Miramar, Florida, United States, 33023 | |
| Suncoast Neuroscience Associates, Inc. | |
| St. Petersburg, Florida, United States | |
| United States, Illinois | |
| Economou & Associates, LTD | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| Michigan Pain and Neurological Institute | |
| Ann Arbor, Michigan, United States | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| NY Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Medical College of Ohio | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oklahoma | |
| COR Clinical Research, LLC | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Pennsylvania | |
| Neurological Associates of Delaware Valley | |
| Upland, Pennsylvania, United States, 19013 | |
| Westmoreland Neurology Associates Inc. | |
| Greensburg, Pennsylvania, United States, 15601 | |
| United States, Texas | |
| Diabetes & Glandular Disease Research Associates, PA | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Monarch Medical Research | |
| Norfolk, Virginia, United States, 23502 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
More Information
| Study ID Numbers: | 20,762-401 |
| Study First Received: | September 30, 2002 |
| Last Updated: | November 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00046475 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypotension Shy-Drager Syndrome Neurotransmitter Agents Adrenergic alpha-Agonists Hypotension, Orthostatic Ganglion Cysts Adrenergic Agents Basal Ganglia Diseases Vascular Diseases Central Nervous System Diseases Cardiovascular Agents |
Brain Diseases Neurodegenerative Diseases Adrenergic Agonists Autonomic Nervous System Diseases Multiple System Atrophy Movement Disorders Vasoconstrictor Agents Midodrine Postural Hypotension Atrophy Peripheral Nervous System Agents |
|
Hypotension Neurotransmitter Agents Hypotension, Orthostatic Adrenergic Agents Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Physiological Effects of Drugs Neurodegenerative Diseases Brain Diseases Adrenergic Agonists Autonomic Nervous System Diseases Movement Disorders Therapeutic Uses Midodrine |
Vasoconstrictor Agents Cardiovascular Diseases Shy-Drager Syndrome Adrenergic alpha-Agonists Sympathomimetics Nervous System Diseases Vascular Diseases Central Nervous System Diseases Cardiovascular Agents Pharmacologic Actions Multiple System Atrophy Autonomic Agents Peripheral Nervous System Agents |