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Sponsored by: |
Mount Sinai School of Medicine |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004478 |
Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880.
RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal.
It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension.
PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.
Condition | Intervention |
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Shy-Drager Syndrome Orthostatic Hypotension |
Drug: droxidopa |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Study of Droxidopa in Patients With Neurologic Hypotension |
Study Start Date: | March 1999 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
PROTOCOL OUTLINE:
Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 |
Study Chair: | Horacio Kaufmann, MD | New York University School of Medicine |
Study ID Numbers: | 199/14180, MTS-GCO-98-243-3-NE |
Study First Received: | October 18, 1999 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00004478 History of Changes |
Health Authority: | Unspecified |
Shy-Drager Syndrome cardiovascular and respiratory diseases neurologic and psychiatric disorders orthostatic hypotension rare disease |
Hypotension Shy-Drager Syndrome Hypotension, Orthostatic Ganglion Cysts Respiration Disorders Basal Ganglia Diseases Rare Diseases Vascular Diseases Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Autonomic Nervous System Diseases Multiple System Atrophy Movement Disorders Mental Disorders Droxidopa Postural Hypotension Atrophy |
Hypotension Shy-Drager Syndrome Disease Hypotension, Orthostatic Anti-Dyskinesia Agents Nervous System Diseases Basal Ganglia Diseases Vascular Diseases Antiparkinson Agents Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Pharmacologic Actions Pathologic Processes Autonomic Nervous System Diseases Multiple System Atrophy Movement Disorders Therapeutic Uses Syndrome Droxidopa Cardiovascular Diseases Central Nervous System Agents |