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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Orthostatic Hypotension

Intervention / Treatment
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* Drug: Droxidopa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator Histories of hypersensitive to droxidopa Histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator Histories of hemorrhage complication within 3 months before the screening visit, such as GI bleeding, intracranial bleeding or traumatic hemorrhage, and are not suitable to participate the trial as judged by the investigator In investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Droxidopa, antihypotensive drug, tablet<br> | Drug: Droxidopa<br>* 200mg/tab 2tablets, po, three times a week<br>|
| Placebo Comparator: placebo, tablet<br> | Drug: Placebo<br>* 200mg/tab, po, three times a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean ΔSBP after hemodialysis | ΔSBP = supine SBP (right before standing up) - nadir standing SBP | from Week 0 (visit 1-3) to Week 4 (visit 13-15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event,Serious adverse event |  | from week 0 to week 5 |