Orthostatic HypotensionPhase 3OHNCT01612078
Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients
A Phase 3 study testing Droxidopa in people with Orthostatic Hypotension, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Droxidopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Droxidopa, Placebo
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroxidopaDrug
200mg/tab 2tablets, po, three times a week
PlaceboDrug
200mg/tab, po, three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Droxidopa, antihypotensive drug, tablet | Experimental | Not described Receives: Drug: Droxidopa |
| placebo, tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean ΔSBP after hemodialysis
ΔSBP = supine SBP (right before standing up) - nadir standing SBP
Measured: from Week 0 (visit 1-3) to Week 4 (visit 13-15)
Secondary outcomes (1)
Adverse event,Serious adverse event
Measured: from week 0 to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mai-Szu Wu, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612078
- Sponsor's protocol ID
- TSHDX1101
- Acronym
- OH
- Status last verified
- Mar 2013
- First submitted
- 1 Jun 2012
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01612078
- Acronym / sponsor ID
- OH / TSHDX1101
- Conditions
- Orthostatic Hypotension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Droxidopa, antihypotensive drug, tablet | Experimental | Drug: Droxidopa |
| placebo, tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Droxidopa200mg/tab 2tablets, po, three times a week | Drug | Droxidopa, antihypotensive drug, tablet |
| Placebo200mg/tab, po, three times a week. | Drug | placebo, tablet |
Primary outcome
Change in mean ΔSBP after hemodialysis
Time frame: from Week 0 (visit 1-3) to Week 4 (visit 13-15)
ΔSBP = supine SBP (right before standing up) - nadir standing SBP
1 secondary outcome
Adverse event,Serious adverse event
Time frame: from week 0 to week 5
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
Related trials for Orthostatic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Diurnal Variability
Orthostatic Hypotension
Active, not recruiting
Water and the Gastropressor Response - Tachyphylaxis
Orthostatic Hypotension
Not yet recruiting
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Szu Wu principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Droxidopa in people with Orthostatic Hypotension, run by TSH Biopharm Corporation Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean ΔSBP after hemodialysis (time frame: from Week 0 (visit 1-3) to Week 4 (visit 13-15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.