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Bosentan and Pulmonary Endothelial Function (PARBO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT01721564
First received: November 1, 2012
Last updated: January 21, 2013
Last verified: January 2013
  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: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Artery Remodelling With Bosentan

Resource links provided by NLM:


Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • Acetylcholine Vascular Reactivity Response [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Percent pulmonary flow change from baseline after acetylcholine


Secondary Outcome Measures:
  • Intravascular Ultrasound - Pulmonary Artery Wall Thickness [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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: NCT00595049
Study First Received: November 1, 2012
Results First Received: December 4, 2012
Last Updated: January 21, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014