Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000289516
Ethics application status
Approved
Date submitted
6/07/2006
Date registered
7/07/2006
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulmonary Artery Remodelling With Bosentan
Scientific title
Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH)
Universal Trial Number (UTN)
Trial acronym
PARBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 1264 0
Condition category
Condition code
Cardiovascular 1350 1350 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bosentan be orally administered at 62.5mg bid for 4 weeks, followed by a target dose of 125mg bid for 6 months
Intervention code [1] 1180 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1840 0
Change from baseline (BL) to 6 mths in the intravascular ultrasound (IVUS)-derived measurement of pulmonary artery wall thickness.
Timepoint [1] 1840 0
Primary outcome [2] 1841 0
Change from BL to 6 mths in pulmonary microvascular circulation (PMVC) dilator responses to actylcholine (Ach).
Timepoint [2] 1841 0
Secondary outcome [1] 3226 0
Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.; Change from BL to 6 mths in PMVC (dilator responses to sodium nitroprusside.
Timepoint [1] 3226 0
Secondary outcome [2] 3227 0
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in pulmonary vascular resistance (PVR).
Timepoint [2] 3227 0
Secondary outcome [3] 3228 0
Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in six minute walk distance (6MWD).
Timepoint [3] 3228 0

Eligibility
Key inclusion criteria
Symptomatic (modified New York Heart Associate (NYHA) class III) iPAH or PAH-SScPAH confirmed by right heart catheterisation performed within 3 months before enrolment, mean pulmonary artery pressure (mPAP) > 25mmHg, pulmonary capillary wedge pressure (PCWP) < 15 mmHg and PVR > 3 mmHg/l/minWomen 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 patientsSigned written informed consent
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PAH other than iPAH or PAH-SScSignificant 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: Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Vapacity (FVC) < 0.5Severe restrictive lung disease: Total Lung Capacity (TLC) < 0.7 of normal predicted valueHemoglobin <75% of the lower limit of the normal rangeSystolic blood pressure < 85 mmHgBody weight < 40 kgPregnancy or breast-feedingModerate to severe hepatic impairment, i.e., Child-Pugh Class B or C.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 treatmentTreatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.Current treatment with cyclosporine A or tacrolimusHypersensitivity 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 treatmentConditions that prevent compliance with the protocol or adherence to therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1480 0
Commercial sector/Industry
Name [1] 1480 0
Actelion Phrmaceuticals Australia
Country [1] 1480 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Actelion Phrmaceuticals Australia
Address
Country
Australia
Secondary sponsor category [1] 1304 0
None
Name [1] 1304 0
none
Address [1] 1304 0
Country [1] 1304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2859 0
Royal Prince Alfred Hospital
Ethics committee address [1] 2859 0
Camperdown
Ethics committee country [1] 2859 0
Australia
Date submitted for ethics approval [1] 2859 0
Approval date [1] 2859 0
24/11/2005
Ethics approval number [1] 2859 0
X05-0255

Summary
Brief 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)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35617 0
Address 35617 0
Country 35617 0
Phone 35617 0
Fax 35617 0
Email 35617 0
Contact person for public queries
Name 10369 0
David Celermajer, Professor
Address 10369 0
Royal Prince Alfred Hospital
Missenden Road
New South Wales 2050
Country 10369 0
Australia
Phone 10369 0
+61 2 9515 7110
Fax 10369 0
Email 10369 0
david.celermajer@email.cs.nsw.gov.au
Contact person for scientific queries
Name 1297 0
Tanya Robb
Address 1297 0
Suite 6 13b Narabang Way
Belrose
NSW 2085
Country 1297 0
Australia
Phone 1297 0
+61 2 9486 4600 Ext. 618
Fax 1297 0
Email 1297 0
tanya.robb@actelion.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.