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Droxidopa in Treating Patients With Neurogenic Hypotension

Primary Purpose

Shy-Drager Syndrome, Orthostatic Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
droxidopa
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shy-Drager Syndrome focused on measuring Shy-Drager Syndrome, cardiovascular and respiratory diseases, neurologic and psychiatric disorders, orthostatic hypotension, rare disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
September 17, 2008
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT00004478
Brief Title
Droxidopa in Treating Patients With Neurogenic Hypotension
Official Title
Study of Droxidopa in Patients With Neurologic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shy-Drager Syndrome, Orthostatic Hypotension
Keywords
Shy-Drager Syndrome, cardiovascular and respiratory diseases, neurologic and psychiatric disorders, orthostatic hypotension, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
droxidopa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12885750
Citation
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. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.
Results Reference
result
PubMed Identifier
15666063
Citation
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. doi: 10.1007/s10286-004-0221-z.
Results Reference
result

Learn more about this trial

Droxidopa in Treating Patients With Neurogenic Hypotension

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