NCT01612078

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

A Double-blind, Randomized and Placebo-controlled Study to Evaluate the Efficacy and Safety of L-threo-3,4-dihydroxyphenylserine (Droxidopa) on Orthostatic Hypotension Treatment in Hemodialysis Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: TSH Biopharm Corporation Limited · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthostatic Hypotension

Interventions

Type	Name	Description
DRUG	Droxidopa	200mg/tab 2tablets, po, three times a week
DRUG	Placebo	200mg/tab, po, three times a week.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-02-01
• First posted: 2012-06-05
• Last updated: 2013-03-13

Locations

1 site across 1 country: Taiwan