Orthostatic Hypotension
Conditions
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.
Interventions
DRUGDroxidopa
200mg/tab 2tablets, po, three times a week
DRUGPlacebo
200mg/tab, po, three times a week.
Sponsors
TSH Biopharm Corporation Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Female or male aged great than 20 years of age 2. Patient with at least 3 month documented requirement of regular hemodialysis session 3. 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. 4. 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. 5. Willing and able to comply with the study procedure and sign a written informed consent
Exclusion criteria
1. 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 2. Subject with closed angle glaucoma 3. Subject with severe hypertension 4. Subject with liver disorder 5. Subject with Hct great than 36% 6. Subject with confusion, hallucination, or delusion 7. 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 8. Subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium 9. Subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization 10. Subject who use of any investigational product within 4 weeks prior to randomization 11. Subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator 12. Histories of hypersensitive to droxidopa 13. Histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator 14. 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 15. In investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean ΔSBP after hemodialysis | from Week 0 (visit 1-3) to Week 4 (visit 13-15) | ΔSBP = supine SBP (right before standing up) - nadir standing SBP |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event,Serious adverse event | from week 0 to week 5 |
Countries
Taiwan
Outcome results
None listed