Pulmonary Arterial HypertensionPARBONCT01721564
Bosentan and Pulmonary Endothelial Function
A study testing Bosentan in people with Pulmonary Arterial Hypertension, run by Prof David S Celermajer.
Trial summary
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Bosentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
- Confirmed or invasive haemodynamic:
- Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
- Pulmonary capillary wedge pressure less than 15 millimeters of mercury
- No prior pulmonary hypertension specific therapy
- Ability to provide informed consent
Who cannot join
- Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
- Advanced renal disease
- Previous allergic reaction to contrast agents
About this study
Official title: Pulmonary Artery Remodelling With Bosentan
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Bosentan
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetylcholine Vascular Reactivity Response
Percent pulmonary flow change from baseline after acetylcholine
Measured: Baseline and 6 months
Secondary outcomes (1)
Intravascular Ultrasound - Pulmonary Artery Wall Thickness
Change in intima-media thickness
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startApr 2006
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof David S Celermajer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia
- Investigators
- David S Celermajer, MBBS, PhD, DSc, Principal investigator, Royal Prince Alfred Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721564
- Sponsor's protocol ID
- X05-0255
- Acronym
- PARBO
- Status last verified
- Oct 2016
- First submitted
- 1 Nov 2012
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Remodelling With Bosentan
- ClinicalTrials.gov ID
- NCT01721564
- Acronym / sponsor ID
- PARBO / X05-0255
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Prof David S CelermajerUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 25 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: Bosentan62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
- Confirmed or invasive haemodynamic:
- Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
- Pulmonary capillary wedge pressure less than 15 millimeters of mercury
- No prior pulmonary hypertension specific therapy
Key exclusion criteria (3 listed)
- Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
- Advanced renal disease
- Previous allergic reaction to contrast agents
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 |
|---|---|---|
| Bosentan62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months | Drug | Bosentan |
Primary outcome
Acetylcholine Vascular Reactivity Response
Time frame: Baseline and 6 months
Percent pulmonary flow change from baseline after acetylcholine
1 secondary outcome
Intravascular Ultrasound - Pulmonary Artery Wall Thickness
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David S Celermajer, MBBS, PhD, DSc principal investigator
Royal Prince Alfred Hospital, Sydney, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Bosentan in people with Pulmonary Arterial Hypertension, run by Prof David S Celermajer.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acetylcholine Vascular Reactivity Response (time frame: Baseline and 6 months). 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 19 Oct 2016; AzTrials last refreshed its copy on 2 Nov 2026.