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Sponsored by: |
Actelion |
---|---|
Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00595049 |
The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).
The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.
Condition | Intervention | Phase |
---|---|---|
Hypertension, Pulmonary |
Drug: Bosentan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH). |
Estimated Enrollment: | 15 |
Study Start Date: | May 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zaved Hossain | +61 2 9486 4600 ext 618 | zaved.hossain@actelion.com |
Contact: Felicity Watson | +61 2 9486 4600 ext 622 | felicity.watson@actelion.com |
Australia, New South Wales | |
Royal Prince Alfred Hospital | Recruiting |
Camperdown, New South Wales, Australia, 2050 |
Principal Investigator: | David Celermajer, Professor | Royal Prince Alfred Hospital, Camperdown |
Study ID Numbers: | AC-052-416 |
Study First Received: | January 7, 2008 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00595049 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
pulmonary arterial artery hypertension systemic sclerosis |
scleroderma remodelling bosentan tracleer intravascular |
Idiopathic pulmonary hypertension Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Sclerosis Bosentan Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |