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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004479
Other study ID # 199/14181
Secondary ID MTS-GCO-97-160NE
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date March 1999

Study information

Verified date July 2004
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
midodrine


Locations

Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

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