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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

June 1, 2012
March 11, 2013
June 2012
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01612078 on ClinicalTrials.gov Archive Site
Adverse event,Serious adverse event [ Time Frame: from week 0 to week 5 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Orthostatic Hypotension
  • Drug: Droxidopa
    200mg/tab 2tablets, po, three times a week
  • Drug: Placebo
    200mg/tab, po, three times a week.
  • Experimental: Droxidopa, antihypotensive drug, tablet
    Intervention: Drug: Droxidopa
  • Placebo Comparator: placebo, tablet
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01612078
TSHDX1101
Yes
TSH Biopharm Corporation Limited
TSH Biopharm Corporation Limited
Not Provided
Principal Investigator: Mai-Szu Wu Taipei Medical University Hospital
TSH Biopharm Corporation Limited
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP