NCT00581477

Treatment of Orthostatic Hypotension

Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.

Detailed description

We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.

Conditions

• Autonomic Nervous System Diseases
• Orthostatic Hypotension
• Dopamine Beta-Hydroxylase Deficiency
• Orthostatic Intolerance

Interventions

Type	Name	Description
DRUG	Droxidopa Oral Product	Droxidopa administered in increasing dosages up to 300 mg

Timeline

• Start date: 2004-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2007-12-27
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

1 site across 1 country: United States