NCT00004479

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2004

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Syncope

Keywords

neurologic and psychiatric disordersrare diseasesyncope

Interventions

midodrineDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

SyncopeNeurologic ManifestationsMental DisordersRare Diseases

Interventions

Midodrine

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Horacio Kaufmann

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

March 1, 1999

Last Updated

June 24, 2005

Record last verified: 2004-07

Locations

US(1)