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

NCT01612078 | Terminated Phase 3 DMC

• 1 other identifier: TSHDX1101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Change in mean ΔSBP after hemodialysis

  ΔSBP = supine SBP (right before standing up) - nadir standing SBP

  from Week 0 (visit 1-3) to Week 4 (visit 13-15)

Secondary Outcomes (1)

• Adverse event,Serious adverse event

  from week 0 to week 5

Study Arms (2)

Droxidopa, antihypotensive drug, tablet

EXPERIMENTAL

Drug: Droxidopa

placebo, tablet

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Droxidopa DRUG

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

Droxidopa, antihypotensive drug, tablet

Placebo DRUG

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

placebo, tablet

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TSH Biopharm Corporation Limited: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Interventions

Droxidopa

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mai-Szu Wu

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

TW (1)