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

Primary Purpose

Orthostatic Hypotension

Status
Terminated
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Droxidopa
Placebo
Sponsored by
TSH Biopharm Corporation Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Droxidopa, antihypotensive drug, tablet

placebo, tablet

Arm Description

Outcomes

Primary Outcome Measures

Change in mean ΔSBP after hemodialysis
ΔSBP = supine SBP (right before standing up) - nadir standing SBP

Secondary Outcome Measures

Adverse event,Serious adverse event

Full Information

First Posted
June 1, 2012
Last Updated
March 11, 2013
Sponsor
TSH Biopharm Corporation Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01612078
Brief Title
Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients
Acronym
OH
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TSH Biopharm Corporation Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Droxidopa, antihypotensive drug, tablet
Arm Type
Experimental
Arm Title
placebo, tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Droxidopa
Intervention Description
200mg/tab 2tablets, po, three times a week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
200mg/tab, po, three times a week.
Primary Outcome Measure Information:
Title
Change in mean ΔSBP after hemodialysis
Description
ΔSBP = supine SBP (right before standing up) - nadir standing SBP
Time Frame
from Week 0 (visit 1-3) to Week 4 (visit 13-15)
Secondary Outcome Measure Information:
Title
Adverse event,Serious adverse event
Time Frame
from week 0 to week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Szu Wu
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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