Treatment of Orthostatic Hypotension - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00581477

Purpose

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.

Condition	Intervention	Phase
Autonomic Nervous System Diseases Orthostatic Hypotension	Drug: droxidopa Drug: placebo Drug: alpha-methyldopa Drug: carbidopa Drug: metyrosine Drug: levodopa Drug: atomoxetine Drug: metoclopramide	Phase III

MedlinePlus related topics: Autonomic Nervous System Disorders Low Blood Pressure Neurologic Diseases

Drug Information available for: Atomoxetine Atomoxetine hydrochloride Levodopa Metoclopramide Metoclopramide hydrochloride Methyldopa Methyldopa ethyl ester hydrochloride Methyldopate Carbidopa Droxidopa alpha-Methyltyrosine Metyrosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Change in blood pressure with standing [ Time Frame: following 5 days of medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

length of time subject is able to stand [ Time Frame: following 5 days of medication ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator	Drug: placebo same frequency as experimental medication
1: Experimental	Drug: droxidopa up to 300mg four times daily Drug: alpha-methyldopa up to 250mg two times daily Drug: carbidopa up to 25mg four times daily Drug: metyrosine up to 1000mg three times daily Drug: levodopa up to 250mg three times daily Drug: atomoxetine up to 40mg twice daily Drug: metoclopramide up to 10mg four times daily

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581477

Contacts

Contact: Bonnie K Black, RN		adc.research@vanderbilt.edu
Contact: Emily M Garland, PhD		adc.research@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: David Robertson, MD
Sub-Investigator: Emily M Garland, PhD
Sub-Investigator: Italo Biaggioni, MD
Sub-Investigator: Satish R Raj, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

David Robertson, MD

Vanderbilt University

More Information

Autonomic Dysfunction Center Website This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt University ( David Robertson, MD )
Study ID Numbers:	030750, HL056693
Study First Received:	December 22, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00581477
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Vanderbilt University:

autonomic nervous system diseases
blood pressure
congenital
orthostasis
catecholamines

Study placed in the following topic categories:

Hypotension
Levodopa
Hypotension, Orthostatic
Carbidopa
Vascular Diseases
Atomoxetine
Methyldopa

Metoclopramide
Autonomic Nervous System Diseases
Postural hypotension
Dopamine
Alpha-Methyltyrosine
Droxidopa

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Anti-Dyskinesia Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Antiparkinson Agents
Antiemetics
Adrenergic Agonists
Therapeutic Uses
Cardiovascular Diseases
Sympatholytics

Adrenergic alpha-Agonists
Nervous System Diseases
Gastrointestinal Agents
Dopamine Antagonists
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009