Clinical Trial: Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Double-blind, Randomized and Placebo-controlled Study to Evaluate the Efficacy and Safety of L-threo-3,4-dihydroxyphenylserine (Droxidopa) on Orthostatic Hypotension Tre

Brief Summary: Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. Since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.

Detailed Summary:
Sponsor: TSH Biopharm Corporation Limited

Current Primary Outcome: Change in mean ΔSBP after hemodialysis [ Time Frame: from Week 0 (visit 1-3) to Week 4 (visit 13-15) ]

ΔSBP = supine SBP (right before standing up) - nadir standing SBP


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse event,Serious adverse event [ Time Frame: from week 0 to week 5 ]

Original Secondary Outcome: Same as current

Information By: TSH Biopharm Corporation Limited

Dates:
Date Received: June 1, 2012
Date Started: June 2012
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013