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 ]
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