Hypertension, PulmonaryPhase 4NCT00595049
Pulmonary Artery Remodelling With Bosentan
A Phase 4 study testing bosentan in people with Hypertension, Pulmonary, run by Actelion at 1 site in Australia.
Trial summary
The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- bosentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 31 May 2006to 30 Jun 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
- PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP > 25 mmHg, PCWP < 15 mmHg and PVR > 3 mmHg/l/min.
- Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
- Bosentan naïve patients
Who cannot join
- Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to < 40 mmHg with a decrease >= 10 mmHg and with a normal cardiac index (>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC < 0.5
- Severe restrictive lung disease: TLC < 0.7 of normal predicted value
- Hemoglobin <75% of the lower limit of the normal range· Systolic blood pressure < 85 mmHg
- Body weight < 40 kg
- Pregnancy or breast-feeding
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Show all 14Show fewer
- Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 times the upper limit of the normal (ULN) range.
- Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
- Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatment
- Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
- Current treatment with cyclosporine A or tacrolimus
- Hypersensitivity to bosentan or any of the excipients of its formulation.
- Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
- Conditions that prevent compliance with the protocol or adherence to therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).
The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).
The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.
- Conditions
- Hypertension, Pulmonary
- Being tested
- bosentan
- Keywords
- pulmonary, arterial, artery, hypertension, systemic, sclerosis, scleroderma, remodelling, bosentan, tracleer, intravascular
- Medical subject headings
- Hypertension, Pulmonary, Hypertension, Sclerosis, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called Tracleer
Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid
| Study group | Role | What they receive |
|---|---|---|
| bosentan | Experimental | Not described Receives: Drug: bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
Measured: Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).
Measured: Baseline to 6 months
Secondary outcomes (4)
Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.
Measured: Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.
Measured: Baseline to 6 months
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the pulmonary microvascular circulation (PMVC) dilator responses versus changes in PVR.
Measured: Baseline to 6 months
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in 6MWD.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study start31 May 2006
- Primary completion31 Dec 2008
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Celermajer, Professor, Principal investigator, Royal Prince Alfred Hospital, Camperdown
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595049
- Sponsor's protocol ID
- AC-052-416
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2008
- Last updated
- 3 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).
- ClinicalTrials.gov ID
- NCT00595049
- Acronym / sponsor ID
- AC-052-416
- Conditions
- Hypertension, Pulmonary
- Keywords
- pulmonary, arterial, artery, hypertension, systemic, sclerosis, scleroderma, remodelling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 31 May 2006 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 16 Jan 2008 (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.
The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).
The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bosentan | Experimental | Drug: bosentan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
- PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP > 25 mmHg, PCWP < 15 mmHg and PVR > 3 mmHg/l/min.
- Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
- Bosentan naïve patients
Key exclusion criteria (14 listed)
- Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to < 40 mmHg with a decrease >= 10 mmHg and with a normal cardiac index (>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC < 0.5
- Severe restrictive lung disease: TLC < 0.7 of normal predicted value
- Hemoglobin <75% of the lower limit of the normal range· Systolic blood pressure < 85 mmHg
- Body weight < 40 kg
- Pregnancy or breast-feeding
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 |
|---|---|---|
| bosentanAlso: TracleerBosentan 62.5 mg bid for 4 weeks, then 125 mg bid | Drug | bosentan |
Primary outcome
Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
Time frame: Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).
Time frame: Baseline to 6 months
4 secondary outcomes
Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.
Time frame: Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.
Time frame: Baseline to 6 months
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the pulmonary microvascular circulation (PMVC) dilator responses versus changes in PVR.
Time frame: Baseline to 6 months
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in 6MWD.
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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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 Celermajer, Professor principal investigator
Royal Prince Alfred Hospital, Camperdown
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bosentan in people with Hypertension, Pulmonary, run by Actelion at 1 site in Australia.
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 4 inclusion and 14 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 3 Jun 2026. 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 Australia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness. (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. 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 3 Jun 2026.