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Completed

NCT Number: NCT00595049

Pulmonary Artery Remodelling With Bosentan

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Connective Tissue Diseases Hypertension Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Scleroderma, Diffuse Scleroderma, Systemic Sclerosis Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Prince Alfred Hospital

Camperdown, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 naïve 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.

Treatment and study plan

Bosentan

Drug

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

Other names: Tracleer

Primary outcomes

  1. Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.

    Time frame: Baseline to 6 months

  2. Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.

    Time frame: Baseline to 6 months

  2. Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.

    Time frame: Baseline to 6 months

  3. 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.

    Time frame: Baseline to 6 months

  4. 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.

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jan 16, 2008
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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