Pulmonary Artery Remodelling With Bosentan - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00595049

Purpose

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.

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: Bosentan	Phase IV

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).

Further study details as provided by Actelion:

Primary Outcome Measures:

Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).

Secondary Outcome Measures:

Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.
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.
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.

Estimated Enrollment:	15
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women ≥ 18 years of age
Symptomatic (modified NYHA class III) iPAH or PAH-SSc
PAH confirmed by right heart catheterisation performed within 3 months before enrolment mPAP > 25mmHg, 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
Signed written informed consent

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595049

Contacts

Contact: Zaved Hossain	+61 2 9486 4600 ext 618	zaved.hossain@actelion.com
Contact: Felicity Watson	+61 2 9486 4600 ext 622	felicity.watson@actelion.com

Locations

Australia, New South Wales
Royal Prince Alfred Hospital	Recruiting
Camperdown, New South Wales, Australia, 2050

Sponsors and Collaborators

Actelion

Investigators

Principal Investigator:

David Celermajer, Professor

Royal Prince Alfred Hospital, Camperdown

More Information

Study ID Numbers:	AC-052-416
Study First Received:	January 7, 2008
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00595049
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Actelion:

pulmonary
arterial
artery
hypertension
systemic
sclerosis

scleroderma
remodelling
bosentan
tracleer
intravascular

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Sclerosis
Bosentan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009