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

TSH Biopharm Corporation Limited1 site in 1 country25 target enrollmentJune 2012

ConditionsOrthostatic Hypotension

InterventionsDroxidopa Placebo

DrugsDroxidopa Placebo

Overview

Phase: Phase 3
Intervention: Droxidopa
Conditions: Orthostatic Hypotension
Sponsor: TSH Biopharm Corporation Limited
Enrollment: 25
Locations: 1
Primary Endpoint: Change in mean ΔSBP after hemodialysis
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

February 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

TSH Biopharm Corporation Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female or male aged great than 20 years of age
•Patient with at least 3 month documented requirement of regular hemodialysis session
•Patient with a decrease of 20 mmHg in SBP or 10 mmHg in DBP within 5 minutes of standing after the end of hemodialysis in at least 2 of 3 sessions during the screening period.
•Subject with subjective complain of light headedness related to the orthostatic hypotension AND with a VAS score 4 in at least 2 of 3 sessions during the screening period.
•Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria

•Female who is pregnant, lactating or planning to be pregnant within 3 months, or female of childbearing potential who is not using medically recognized method of contraception
•Subject with closed angle glaucoma
•Subject with severe hypertension
•Subject with liver disorder
•Subject with Hct great than 36%
•Subject with confusion, hallucination, or delusion
•Subject with severe disease which may limit survival during the study period, or confound the results of the study as judged by the investigator, such as hyperthyroidism, artery stenosis, severe lung disorders, severe asthma, chronic open angle glaucoma, uncontrolled diabetic gangrene
•Subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium
•Subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization
•Subject who use of any investigational product within 4 weeks prior to randomization