Pulmonary Artery Remodelling With Bosentan

NCT ID: NCT00595049

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-06-30

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).

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.

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bosentan

Group Type: EXPERIMENTAL

bosentan

Intervention Type: DRUG

Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid

Interventions

bosentan

Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid

Intervention Type: DRUG

Other Intervention Names

Tracleer

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Celermajer, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital, Camperdown

Other Identifiers

AC-052-416

Identifier Type: -

Identifier Source: org_study_id