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Pulmonary Artery Remodelling With Bosentan

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary

Intervention: bosentan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
David Celermajer, Professor, Principal Investigator, Affiliation: Royal Prince Alfred Hospital, Camperdown

Summary

The main purpose of this study is to investigate whether bosentan (Tracleerģ) 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.

Clinical Details

Official title: Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 na√Įve 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.

Locations and Contacts

Royal Prince Alfred Hospital, Camperdown, Australia
Additional Information

Starting date: May 2006
Last updated: April 28, 2015

Page last updated: August 23, 2015

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