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

December 22, 2007
May 12, 2014
January 2004
December 2015   (final data collection date for primary outcome measure)
Change in blood pressure with standing [ Time Frame: following 5 days of medication ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581477 on ClinicalTrials.gov Archive Site
length of time subject is able to stand [ Time Frame: following 5 days of medication ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Orthostatic Hypotension
Treatment of Hypotensive Patients Having a Unique Pattern of Autonomic Symptoms

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Autonomic Nervous System Diseases
  • Orthostatic Hypotension
  • Dopamine Beta-Hydroxylase Deficiency
  • Orthostatic Intolerance
  • Drug: droxidopa
    up to 300mg four times daily
  • Drug: placebo
    same frequency as experimental medication
  • 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
  • Placebo Comparator: 2
    Intervention: Drug: placebo
  • Experimental: 1
    Interventions:
    • Drug: droxidopa
    • Drug: alpha-methyldopa
    • Drug: carbidopa
    • Drug: metyrosine
    • Drug: levodopa
    • Drug: atomoxetine
    • Drug: metoclopramide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Bonnie K Black, RN adc.research@vanderbilt.edu
Contact: Emily M Garland, PhD adc.research@vanderbilt.edu
United States
 
NCT00581477
030750, HL056693
No
Emily M. Garland, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: David Robertson, MD Vanderbilt University
Vanderbilt University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP