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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00595049




Registration number
NCT00595049
Ethics application status
Date submitted
7/01/2008
Date registered
16/01/2008
Date last updated
30/04/2015

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).
Secondary ID [1] 0 0
AC-052-416
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bosentan

Experimental: bosentan -


Treatment: Drugs: bosentan
Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
Timepoint [1] 0 0
Baseline to 6 months
Primary outcome [2] 0 0
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).
Timepoint [2] 0 0
Baseline to 6 months
Secondary outcome [1] 0 0
Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.
Timepoint [1] 0 0
Baseline to 6 months
Secondary outcome [2] 0 0
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.
Timepoint [2] 0 0
Baseline to 6 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline to 6 months
Secondary outcome [4] 0 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 6MWD.
Timepoint [4] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
Inclusion Criteria : · Men or women >18 years of age.·

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria : · PAH other than iPAH or PAH-SSc

- 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.

- 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.

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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

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).

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.
Trial website
https://clinicaltrials.gov/show/NCT00595049
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Celermajer, Professor
Address 0 0
Royal Prince Alfred Hospital, Camperdown
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications