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

Sponsor:

Information provided by:

Office of Rare Diseases (ORD)

Study Description

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	Phase
Shy-Drager Syndrome Orthostatic Hypotension	Drug: droxidopa	Not Applicable

Detailed Description:

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 Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple system atrophy Orthostatic hypotension

MedlinePlus related topics: Low Blood Pressure

Drug Information available for: Droxidopa

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

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

Locations

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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

Investigators

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Study Chair:	Horacio Kaufmann, MD	NYU Langone Health

More Information

Publications of Results:

Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. Epub 2003 Jul 28.

Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical pharmacokinetics of the norepinephrine precursor L-threo-DOPS in primary chronic autonomic failure. Clin Auton Res. 2004 Dec;14(6):363-8.

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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

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:

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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

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