Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope - Full Text View

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

This study has been completed.

Sponsored by:	Mount Sinai School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004479

Purpose

OBJECTIVES:

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

Condition	Intervention
Syncope	Drug: midodrine

MedlinePlus related topics:

Fainting

Drug Information available for:

Midodrine Midodrine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:

March 1999

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004479

Locations


United States, New York
	Mount Sinai School of Medicine
	New York, New York, United States, 10029

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators


Study Chair:	Horacio Kaufmann	Mount Sinai School of Medicine

More Information

Study ID Numbers:	199/14181, MTS-GCO-97-160NE, ROBERTS-MTS-GCO-97-160NE
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004479
Health Authority:	Unspecified

Keywords provided by Office of Rare Diseases (ORD):

neurologic and psychiatric disorders

rare disease

syncope

Study placed in the following topic categories:

Signs and Symptoms

Unconsciousness

Mental Disorders

Consciousness Disorders

Midodrine

Rare Diseases

Neurologic Manifestations

Neurobehavioral Manifestations

Syncope

Additional relevant MeSH terms:

Neurotransmitter Agents

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Sympathomimetics

Nervous System Diseases

Physiological Effects of Drugs

Cardiovascular Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Vasoconstrictor Agents

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008