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Bosentan and Pulmonary Endothelial Function

Information source: Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Bosentan (Drug)

Phase: N/A

Status: Completed

Sponsored by: Prof David S Celermajer

Official(s) and/or principal investigator(s):
David S Celermajer, MBBS, PhD, DSc, Principal Investigator, Affiliation: Royal Prince Alfred Hospital, Sydney, Australia

Summary

6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Clinical Details

Official title: Pulmonary Artery Remodelling With Bosentan

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Acetylcholine Vascular Reactivity Response

Secondary outcome: Intravascular Ultrasound - Pulmonary Artery Wall Thickness

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: January 21, 2013

Page last updated: August 23, 2015

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