Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pulmonary Artery Remodelling With Bosentan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00595049
First received: January 7, 2008
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach). [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the pulmonary microvascular circulation (PMVC) dilator responses versus changes in PVR. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in 6MWD. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2006
Study Completion Date: June 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bosentan Drug: bosentan
Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid
Other Name: Tracleer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria : · Men or women >18 years of age.·

  • Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
  • PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP > 25 mmHg, PCWP < 15 mmHg and PVR > 3 mmHg/l/min.
  • Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
  • Bosentan naïve patients

Exclusion Criteria : · PAH other than iPAH or PAH-SSc

  • Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to < 40 mmHg with a decrease >= 10 mmHg and with a normal cardiac index (>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC < 0.5
  • Severe restrictive lung disease: TLC < 0.7 of normal predicted value
  • Hemoglobin <75% of the lower limit of the normal range· Systolic blood pressure < 85 mmHg
  • Body weight < 40 kg
  • Pregnancy or breast-feeding
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
  • Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 times the upper limit of the normal (ULN) range.
  • Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
  • Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatment
  • Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
  • Current treatment with cyclosporine A or tacrolimus
  • Hypersensitivity to bosentan or any of the excipients of its formulation.
  • Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
  • Conditions that prevent compliance with the protocol or adherence to therapy.
  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: NCT00595049

Locations
United States, New York
New York, New York, United States
Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Sponsors and Collaborators
Actelion
Investigators
Principal Investigator: David Celermajer, Professor Royal Prince Alfred Hospital, Camperdown
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00595049     History of Changes
Other Study ID Numbers: AC-052-416
Study First Received: January 7, 2008
Last Updated: March 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Actelion:
pulmonary
arterial
artery
hypertension
systemic
sclerosis
scleroderma
remodelling
bosentan
tracleer
intravascular

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 25, 2014