Treatment of Orthostatic Hypotension
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autonomic Nervous System Diseases; Orthostatic Hypotension
Intervention: droxidopa (Drug); placebo (Drug); alpha-methyldopa (Drug); carbidopa (Drug); metyrosine (Drug); levodopa (Drug); atomoxetine (Drug); metoclopramide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
David Robertson, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Bonnie K Black, RN, Email: adc.research@vanderbilt.edu
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. This study consists of
single dose trials, dose selection trials, 5-day trials and chronic (approximately 2 months)
trials.
Clinical Details
Official title: Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
Study design: Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Change in blood pressure with standing
Secondary outcome: length of time subject is able to stand
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with severe orthostatic hypotension and other autonomic symptoms who do not
meet criteria for one of our standard diagnoses
- non-smokers
- drug-free
- able to give informed consent
- free of pulmonary, renal, hematopoietic, hepatic and cardiac disease
Exclusion Criteria:
- medications affecting the autonomic nervous system
- any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic)
- anemia (Hct < 30)
- women of childbearing age who are pregnant or nursing
- smokers
Locations and Contacts
Bonnie K Black, RN, Email: adc.research@vanderbilt.edu
Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
David Robertson, MD, Principal Investigator
Emily M Garland, PhD, Sub-Investigator
Italo Biaggioni, MD, Sub-Investigator
Satish R Raj, MD, Sub-Investigator
Additional Information
Autonomic Dysfunction Center Website
Starting date: January 2004
Ending date: December 2008
Last updated: August 8, 2008
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