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)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000289516

Acronym

PARBO

Enrollment

Registered

2006-07-07

Start date

2006-07-31

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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)

Interventions

Bosentan be orally administered at 62.5mg bid for 4 weeks, followed by a target dose of 125mg bid for 6 months

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Symptomatic (modified New York Heart Associate (NYHA) class III) iPAH or PAH-SScPAH confirmed by right heart catheterisation performed within 3 months before enrolment, mean pulmonary artery pressure (mPAP) > 25mmHg, pulmonary capillary wedge pressure (PCWP) < 15 mmHg and PVR > 3 mmHg/l/minWomen 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 patientsSigned written informed consent

Exclusion criteria

PAH other than iPAH or PAH-SScSignificant 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: Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Vapacity (FVC) < 0.5Severe restrictive lung disease: Total Lung Capacity (TLC) < 0.7 of normal predicted valueHemoglobin <75% of the lower limit of the normal rangeSystolic blood pressure < 85 mmHgBody weight < 40 kgPregnancy or breast-feedingModerate 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 treatmentTreatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.Current treatment with cyclosporine A or tacrolimusHypersensitivity 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 treatmentConditions that prevent compliance with the protocol or adherence to therapy.

Outcome results