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Bosentan and Pulmonary Endothelial Function (PARBO)

This study has been completed.
Information provided by (Responsible Party):
Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia Identifier:
First received: November 1, 2012
Last updated: October 18, 2016
Last verified: October 2016
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Condition Intervention
Pulmonary Arterial Hypertension
Drug: Bosentan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Artery Remodelling With Bosentan

Resource links provided by NLM:

Further study details as provided by Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • Acetylcholine Vascular Reactivity Response [ Time Frame: Baseline and 6 months ]
    Percent pulmonary flow change from baseline after acetylcholine

Secondary Outcome Measures:
  • Intravascular Ultrasound - Pulmonary Artery Wall Thickness [ Time Frame: baseline and 6 months ]
    Change in intima-media thickness

Enrollment: 8
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bosentan
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Drug: Bosentan
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
  • Confirmed or invasive haemodynamic:
  • Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
  • Pulmonary capillary wedge pressure less than 15 millimeters of mercury
  • No prior pulmonary hypertension specific therapy
  • Ability to provide informed consent

Exclusion Criteria:

  • Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
  • Advanced renal disease
  • Previous allergic reaction to contrast agents
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Please refer to this study by its identifier: NCT01721564

Sponsors and Collaborators
Prof David S Celermajer
Principal Investigator: David S Celermajer, MBBS, PhD, DSc Royal Prince Alfred Hospital, Sydney, Australia
  More Information

Responsible Party: Prof David S Celermajer, Scandrett Professor of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia Identifier: NCT01721564     History of Changes
Other Study ID Numbers: X05-0255
Study First Received: November 1, 2012
Results First Received: December 4, 2012
Last Updated: October 18, 2016

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017