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

Orthostatic Hypotension Clinical Trial

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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 Treatment in Hemodialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01612078
• Other study ID #: TSHDX1101
• Status: Terminated
• Phase: Phase 3
• First received: June 1, 2012
• Last updated: March 11, 2013
• Start date: June 2012

Study information

• Verified date: March 2013
• Source: TSH Biopharm Corporation Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Drug:
• Droxidopa
200mg/tab 2tablets, po, three times a week
• Placebo
200mg/tab, po, three times a week.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TSH Biopharm Corporation Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean ?SBP after hemodialysis	?SBP = supine SBP (right before standing up) - nadir standing SBP	from Week 0 (visit 1-3) to Week 4 (visit 13-15)	No
Secondary	Adverse event,Serious adverse event		from week 0 to week 5	Yes