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Treatment of Orthostatic Hypotension

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University Identifier:
First received: December 22, 2007
Last updated: April 3, 2017
Last verified: April 2017
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
Dopamine Beta-Hydroxylase Deficiency
Orthostatic Intolerance
Drug: droxidopa
Drug: placebo
Drug: alpha-methyldopa
Drug: carbidopa
Drug: metyrosine
Drug: levodopa
Drug: atomoxetine
Drug: metoclopramide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

Resource links provided by NLM:

Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Change in blood pressure with standing [ Time Frame: following 5 days of medication ]

Secondary Outcome Measures:
  • length of time subject is able to stand [ Time Frame: following 5 days of medication ]

Estimated Enrollment: 25
Study Start Date: January 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00581477

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: David Robertson, MD Vanderbilt University
  More Information

Additional Information:
Responsible Party: Emily M. Garland, Research Associate Professor, Vanderbilt University Identifier: NCT00581477     History of Changes
Other Study ID Numbers: 030750
Study First Received: December 22, 2007
Last Updated: April 3, 2017

Keywords provided by Vanderbilt University Medical Center:
autonomic nervous system diseases
blood pressure

Additional relevant MeSH terms:
Nervous System Diseases
Orthostatic Intolerance
Hypotension, Orthostatic
Autonomic Nervous System Diseases
Primary Dysautonomias
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Atomoxetine Hydrochloride
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists processed this record on April 25, 2017