Droxidopa in Treating Patients With Neurogenic Hypotension

This study has been completed.
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004478
First received: October 18, 1999
Last updated: September 17, 2008
Last verified: September 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Syndrome
Hypotension
Hypotension, Orthostatic
Shy-Drager Syndrome
Multiple System Atrophy
Disease
Pathologic Processes
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 September 18, 2014