Treatment of Orthostatic Hypotension - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

Resource links provided by NLM:

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

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

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

Placebo Comparator: 2

Drug: placebo

same frequency as experimental medication

Experimental: 1

Drug: droxidopa

up to 300mg four times daily

Drug: alpha-methyldopa

up to 250mg two times daily

Other Name: Aldomet

Drug: carbidopa

up to 25mg four times daily

Other Name: Lodosyn

Drug: metyrosine

up to 1000mg three times daily

Other Name: Demser

Drug: levodopa

up to 250mg three times daily

Other Name: Larodopa

Drug: atomoxetine

up to 40mg twice daily

Other Name: Strattera

Drug: metoclopramide

up to 10mg four times daily

Other Name: Reglan

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

Additional Information:

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

No publications provided

Responsible Party:	David Robertson, MD, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00581477 History of Changes
Other Study ID Numbers:	030750, HL056693
Study First Received:	December 22, 2007
Last Updated:	February 17, 2011
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

Additional relevant MeSH terms:

Autonomic Nervous System Diseases
Primary Dysautonomias
Hypotension
Hypotension, Orthostatic
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Droxidopa
Carbidopa
Levodopa
Metoclopramide
Alpha-Methyltyrosine
Methyldopa
Atomoxetine

Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 12, 2012