Back to resultsRandomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope
Primary Purpose
Syncope
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
midodrine
Sponsored by
About this trial
This is an interventional treatment trial for Syncope focused on measuring neurologic and psychiatric disorders, rare disease, syncope
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control
Sites / Locations
- Mount Sinai School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004479
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00004479
Brief Title
Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope
Study Type
Interventional
2. Study Status
Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES:
Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study.
On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
neurologic and psychiatric disorders, rare disease, syncope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
midodrine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope
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