Clinical Trial: Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic

Brief Summary: The purpose of this study is to determine whether midodrine works against the symptoms of orthostatic hypotension caused by being on a tilt table.

Detailed Summary: The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 4 overnight stays.
Sponsor: Shire

Current Primary Outcome: Time to Onset of Syncope/Near Syncope While on Tilt Table [ Time Frame: 1 hour post-dose ]

After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.


Original Primary Outcome: Time to Onset of Syncope/Near Syncope While on Tilt Table [ Time Frame: 1 hour post-dose ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: January 18, 2012
Date Started: May 2012
Date Completion:
Last Updated: October 10, 2014
Last Verified: July 2014