Expired Study
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New York, New York 10029


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

199/14181


NCT ID:

NCT00004479


Secondary ID:

MTS-GCO-97-160NE


Study Acronym:


Brief Title:

Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Office of Rare Diseases (ORD)


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Horacio Kaufmann
Study Chair
Mount Sinai School of Medicine

Study Dates

Start Date:March 1999
Verification Date:July 2004
Last Changed Date:June 23, 2005
First Received Date:October 18, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:midodrine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mount Sinai School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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