Droxidopa in Treating Patients With Neurogenic Hypotension
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ClinicalTrials.gov Identifier: NCT00004478 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : September 18, 2008
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Shy-Drager Syndrome Orthostatic Hypotension | Drug: droxidopa | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Study of Droxidopa in Patients With Neurologic Hypotension |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | March 2006 |


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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision
- History of syncope or near-syncope
--Prior/Concurrent Therapy--
- Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed
- Other: Concurrent indomethacin, support garments, and high salt diets allowed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004478
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 |
Study Chair: | Horacio Kaufmann, MD | NYU Langone Health |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00004478 History of Changes |
Other Study ID Numbers: |
199/14180 MTS-GCO-98-243-3-NE |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | September 18, 2008 |
Last Verified: | September 2008 |
Shy-Drager Syndrome cardiovascular and respiratory diseases neurologic and psychiatric disorders orthostatic hypotension rare disease |
Hypotension, Orthostatic Shy-Drager Syndrome Multiple System Atrophy Hypotension Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases |
Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Droxidopa Antiparkinson Agents Anti-Dyskinesia Agents |