Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Orthostatic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581477
Recruitment Status : Enrolling by invitation
First Posted : December 27, 2007
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment 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

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms
Study Start Date : January 2004
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581477


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: David Robertson, MD Vanderbilt University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Emily M. Garland, Research Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581477    
Other Study ID Numbers: 030750
HL056693
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Keywords provided by Emily M. Garland, Vanderbilt University:
autonomic nervous system diseases
blood pressure
congenital
orthostasis
catecholamines
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases
Hypotension, Orthostatic
Orthostatic Intolerance
Autonomic Nervous System Diseases
Primary Dysautonomias
Hypotension
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Methyldopa
Levodopa
Carbidopa
Droxidopa
Metoclopramide
Atomoxetine Hydrochloride
 alpha-Methyltyrosine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Antiemetics
Autonomic Agents