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Bosentan and Pulmonary Endothelial Function (PARBO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721564
First Posted: November 5, 2012
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721564


Sponsors and Collaborators
Prof David S Celermajer
Investigators
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
ClinicalTrials.gov Identifier: NCT01721564     History of Changes
Other Study ID Numbers: X05-0255
First Submitted: November 1, 2012
First Posted: November 5, 2012
Results First Submitted: December 4, 2012
Results First Posted: February 25, 2013
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action