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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

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.

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Detailed Description

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Conditions

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Orthostatic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Droxidopa, antihypotensive drug, tablet

Group Type EXPERIMENTAL

Droxidopa

Intervention Type DRUG

200mg/tab 2tablets, po, three times a week

placebo, tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

200mg/tab, po, three times a week.

Interventions

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Droxidopa

200mg/tab 2tablets, po, three times a week

Intervention Type DRUG

Placebo

200mg/tab, po, three times a week.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No