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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
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

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
Shy-Drager Syndrome Orthostatic Hypotension Drug: droxidopa

Detailed Description:


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
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Droxidopa
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Study Chair: Horacio Kaufmann, MD New York University School of Medicine

ClinicalTrials.gov Identifier: NCT00004478     History of Changes
Other Study ID Numbers: 199/14180
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: September 18, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
Shy-Drager Syndrome
cardiovascular and respiratory diseases
neurologic and psychiatric disorders
orthostatic hypotension
rare disease

Additional relevant MeSH terms:
Hypotension, Orthostatic
Shy-Drager Syndrome
Multiple System Atrophy
Orthostatic Intolerance
Autonomic Nervous System Diseases
Nervous System Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents