Bosentan and Pulmonary Endothelial Function
PARBO
Pulmonary Artery Remodelling With Bosentan
1 other identifier
interventional
8
0 countries
N/A
Brief Summary
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 5, 2012
CompletedResults Posted
Study results publicly available
February 25, 2013
CompletedOctober 19, 2016
October 1, 2016
3.1 years
November 1, 2012
December 4, 2012
October 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Acetylcholine Vascular Reactivity Response
Percent pulmonary flow change from baseline after acetylcholine
Baseline and 6 months
Secondary Outcomes (1)
Intravascular Ultrasound - Pulmonary Artery Wall Thickness
baseline and 6 months
Study Arms (1)
Bosentan
EXPERIMENTAL62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Interventions
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof David Celermajer
- Organization
- Royal Prince Alfred Hospital, Sydney, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
David S Celermajer, MBBS, PhD, DSc
Royal Prince Alfred Hospital, Sydney, Australia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Scandrett Professor of Cardiology
Study Record Dates
First Submitted
November 1, 2012
First Posted
November 5, 2012
Study Start
April 1, 2006
Primary Completion
May 1, 2009
Study Completion
December 1, 2009
Last Updated
October 19, 2016
Results First Posted
February 25, 2013
Record last verified: 2016-10