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 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