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

This study has been completed.
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004479
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2004
  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: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00004479     History of Changes
Other 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
Health Authority: Unspecified

Keywords provided by Office of Rare Diseases (ORD):
neurologic and psychiatric disorders
rare disease
syncope

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adrenergic alpha-Agonists
Midodrine
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists

ClinicalTrials.gov processed this record on August 20, 2014