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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Fainting

Drug Information available for: Midodrine Midodrine hydrochloride

U.S. FDA Resources

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

No publications provided

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

Unconsciousness
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Consciousness Disorders
Rare Diseases
Cardiovascular Agents
Syncope

Adrenergic Agonists
Signs and Symptoms
Mental Disorders
Vasoconstrictor Agents
Midodrine
Neurologic Manifestations
Peripheral Nervous System Agents
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Unconsciousness
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Consciousness Disorders
Nervous System Diseases
Cardiovascular Agents
Syncope

Pharmacologic Actions
Adrenergic Agonists
Signs and Symptoms
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Midodrine
Neurologic Manifestations
Peripheral Nervous System Agents
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on July 02, 2009