Pulmonary Artery Remodelling With Bosentan

• Register: ClinicalTrials.gov
• Last refreshed on: 11 May 2015
• Main ID: NCT00595049
• Date of registration: 07/01/2008
• Prospective Registration: No
• Primary sponsor: Actelion
• 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).
• Date of first enrolment: May 2006
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00595049
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Australia, United States

Contacts

• Name: David Celermajer, Professor
• Affiliation: Royal Prince Alfred Hospital, Camperdown

Key inclusion & exclusion 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

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: bosentan

Primary Outcome(s)

Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach). [Time Frame: Baseline to 6 months]

Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness. [Time Frame: Baseline to 6 months]

Secondary Outcome(s)

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]

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 PMVC dilator responses versus changes in 6MWD. [Time Frame: Baseline to 6 months]

Secondary ID(s)

AC-052-416

Source(s) of Monetary Support

Please refer to primary and secondary sponsors