Droxidopa in Treating Patients With Neurogenic Hypotension - Full Text View

Sponsor:	Mount Sinai School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004478

Purpose

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
Shy-Drager Syndrome Orthostatic Hypotension	Drug: droxidopa

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Study of Droxidopa in Patients With Neurologic Hypotension

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia multiple system atrophy

MedlinePlus related topics: Low Blood Pressure

Drug Information available for: Droxidopa

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:	March 1999
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004478

Locations

United States, New York
New York University School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators

Study Chair:

Horacio Kaufmann, MD

New York University School of Medicine

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00004478 History of Changes
Other Study ID Numbers:	199/14180, MTS-GCO-98-243-3-NE
Study First Received:	October 18, 1999
Last Updated:	September 17, 2008
Health Authority:	Unspecified

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
Hypotension, Orthostatic
Shy-Drager Syndrome
Multiple System Atrophy
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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012