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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier:
NCT01612078
First received: June 1, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Orthostatic Hypotension
 Drug: Droxidopa
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TSH Biopharm Corporation Limited:

Primary Outcome Measures:
  • Change in mean ΔSBP after hemodialysis [ Time Frame: from Week 0 (visit 1-3) to Week 4 (visit 13-15) ] [ Designated as safety issue: No ]
    ΔSBP = supine SBP (right before standing up) - nadir standing SBP


Secondary Outcome Measures:
  • Adverse event,Serious adverse event [ Time Frame: from week 0 to week 5 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: June 2012
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Droxidopa, antihypotensive drug, tablet Drug: Droxidopa
200mg/tab 2tablets, po, three times a week
Placebo Comparator: placebo, tablet Drug: Placebo
200mg/tab, po, three times a week.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612078

Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
TSH Biopharm Corporation Limited
Investigators
Principal Investigator: Mai-Szu Wu Taipei Medical University Hospital
  More Information

No publications provided

Responsible Party: TSH Biopharm Corporation Limited
ClinicalTrials.gov Identifier: NCT01612078     History of Changes
Other Study ID Numbers: TSHDX1101
Study First Received: June 1, 2012
Last Updated: March 11, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Orthostatic Intolerance
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
 Nervous System Diseases
Droxidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013