Droxidopa in Treating Patients With Neurogenic Hypotension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shy-Drager Syndrome Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Disease Attributes Hypotension Hypotension, Orthostatic Mental Disorders Movement Disorders Multiple System Atrophy Nervous System Diseases Neurologic Manifestations Orthostatic Hypotension Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias Rare Diseases Respiratory Tract Diseases Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Droxidopa

Drug

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Study of Droxidopa in Patients With Neurologic Hypotension

Important dates

Study start: 1999
Primary completion: 2006
Study completion: 2006
First posted: Oct 19, 1999
Registry last updated: Sep 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed