Treatment of Orthostatic Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Emily M. Garland, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581477
First received: December 22, 2007
Last updated: May 12, 2014
Last verified: May 2014
  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
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
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:


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 2015
Estimated Primary Completion Date: December 2015 (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.

  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
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, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Emily M. Garland, Research Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581477     History of Changes
Other Study ID Numbers: 030750, HL056693
Study First Received: December 22, 2007
Last Updated: May 12, 2014
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:
Nervous System Diseases
Autonomic Nervous System Diseases
Hypotension
Hypotension, Orthostatic
Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Primary Dysautonomias
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Anxiety Disorders
Mental Disorders
Methyldopa
Metoclopramide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on October 19, 2014