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NCT01456481 · ClinicalTrials.gov registry record · Phase 4

Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV

A Phase 4 study of Vasovagal Syncope, sponsored by Dr. Bob Sheldon.

Active
Registry status
Phase 4
Development phase
134
Enrollment target
17
Study locations

NCT01456481 is a Phase 4 study of Vasovagal Syncope that is active but no longer recruiting, run by Dr. Bob Sheldon. The registered enrollment target is 134 participants. The trial reports 17 study locations across 11 states.

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The verdict

NCT01456481, a Phase 4 study of Vasovagal Syncope, is active but no longer recruiting, sponsored by Dr. Bob Sheldon.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
134 participants
Enrollment target
17
Study locations

Study Summary

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope. The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.

Conditions Studied

Interventions

  • DRUG matching placebo
  • DRUG midodrine hydrochloride

Study Locations (17)

Alberta

  • University of Calgary - Calgary
  • Alberta Health Services - Royal Alexandra Hospital - Edmonton
  • Royal Alexandra Hospital - Edmonton
  • Red Deer Regional Hospital - Red Deer

Ontario

  • Hamilton Health Sciences - Hamilton
  • University of Ottawa Heart Institute - Ottawa

Quebec

  • Hopital Sacre Coeur de Montreal - Montreal
  • Centre Hospitalier Universitaire de Sherbrooke - Sherbrooke

Saskatchewan

  • Prairie Vascular Research Network/Regina General Hospital - Regina
  • Saskatoon Cardiology Consultants/Royal University Hospital - Saskatoon

Minnesota

  • University of Minnesota - Minneapolis

Tennessee

  • Vanderbilt University - Nashville

British Columbia

  • Victoria Cardiac Arrythmia Trials - Victoria

Manitoba

  • St. Boniface General Hospital - St. Boniface

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2011-11
Est. Completion 2024-12-31
Phase Phase 4

Sponsor

Dr. Bob Sheldon

1 total trials

What the Registry Record Tells You About NCT01456481

The ClinicalTrials.gov registry entry for NCT01456481 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Bob Sheldon, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vasovagal Syncope appearing as the primary indexed condition, and to 2 interventions - of which matching placebo is the first listed.

NCT01456481 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Alberta, Ontario, Quebec.

Frequently Asked Questions

What is clinical trial NCT01456481 about?

NCT01456481 is a clinical study titled "Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV". About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug ...

What is the current status of trial NCT01456481?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 134 participants. The study started on 2011-11. Estimated completion is 2024-12-31.

What conditions does trial NCT01456481 study?

This clinical trial studies the following conditions: Vasovagal Syncope.

What interventions are being tested in trial NCT01456481?

The interventions under investigation include: matching placebo (DRUG), midodrine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01456481?

This trial is sponsored by Dr. Bob Sheldon, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01456481 being conducted?

This trial has 17 study locations across Minnesota, Tennessee, Alberta, British Columbia, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.