Pulmonary Artery Remodelling With Bosentan

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

NCT00595049•Actelion

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.
+4 more criteria

Key Dates

Start Date

May 1, 2006

Primary Completion Date

December 1, 2008

Completion Date

June 1, 2010

Last Updated

February 3, 2025

Enrollment

ACTUAL participants

Conditions

Hypertension, Pulmonary

Interventions

bosentan

DRUG

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

NCT07079592

Artificial Intelligence (AI)Artificial Intelligence (AI) in Diagnosis+1 more

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RECRUITINGNA

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

NCT05719415

Hypertension, PulmonaryPulmonary Thromboembolisms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pulmonary Artery Remodelling With Bosentan

Inclusion Criteria

Exclusion Criteria

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

Real-World Study of PADN for the Treatment of PAH

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)