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Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

This study has been completed.
Information provided by:
Actelion Identifier:
First received: April 10, 2006
Last updated: February 11, 2010
Last verified: February 2010
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

Condition Intervention Phase
Chronic Thromboembolic Pulmonary Hypertension
Drug: bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change from Baseline to Week 16 in 6-Minute Walk Test distance [ Time Frame: Week 16 ]
  • Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • Change from Baseline to Week 16 in modified NYHA functional class [ Time Frame: Week 16 ]
  • Time to clinical worsening [ Time Frame: Time to clinical worsening ]

Enrollment: 157
Study Start Date: October 2005
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic pulmonary hypertension in modified NYHA functional class II to IV due to CTEPH as demonstrated by ventilation/perfusion lung scanning and pulmonary angiography.
  • CTEPH judged inoperable because of peripheral localization of thrombotic material or persistent or recurrent pulmonary hypertension after pulmonary endarterectomy (PEA) with no evidence of recurrent thromboembolism and not amenable to repeated surgery.
  • 6-minute walk test (6MWT) distance < 450 m.
  • Hemodynamic evaluation showing: Mean pulmonary arterial pressure (mPAP) >= 25 mmHg; Pulmonary capillary wedge pressure (PCWP) < 15 mmHg; Pulmonary vascular resistance (PVR) at rest >= 300 dyn×sec/cm5
  • For patients who underwent PEA, hemodynamic evaluation must have been performed more than 6 months after PEA.
  • For all patients, hemodynamic evaluation must have been performed with the 3 months immediately preceding inclusion.
  • Men or women >= 18 and =< 80 years of age (Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception).
  • Anticoagulants at efficacious dose for at least 3 months prior to randomization.
  • Signed informed consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  • Other forms of pulmonary hypertension including pulmonary hypertension related to sickle cell disease.
  • Obstructive lung disease: FEV1/FVC < 0.5 after bronchodilator.
  • Severe restrictive lung disease: Total Lung Capacity < 60% of predicted value.
  • Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (in particular with 6MWT), e.g., angina pectoris, intermittent claudication.
  • Symptomatic pulmonary embolism within 6 months prior to randomization.
  • Pulmonary endarterectomy within 6 months prior to randomization.
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
  • Illness with a life expectancy of less than 6 months.
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
  • AST and/or ALT > 3 times the upper limit of normal ranges.· Hemoglobin concentration < 75% the lower limit of normal ranges.
  • Pregnancy or breast-feeding.
  • Systolic blood pressure (BP) < 85 mmHg.
  • Treatment or planned treatment with another investigational drug and/or pulmonary angioplasty within 3 months prior to randomization.
  • Treatment with an endothelin receptor antagonist, a phosphodiesterase inhibitor, L-arginine or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 3 months prior to randomization.
  • Treatment for pulmonary hypertension within 1 month prior to randomization, excluding calcium channel blockers if present for at least 1 month before randomization.
  • Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus), sirolimus, fluconazole, glibenclamide (glyburide) within 1 week prior to randomization.
  • Known hypersensitivity to bosentan or any of the excipients.
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Please refer to this study by its identifier: NCT00313222

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Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sebastien Roux, MD, Actelion Identifier: NCT00313222     History of Changes
Other Study ID Numbers: AC-052-366
Study First Received: April 10, 2006
Last Updated: February 11, 2010

Keywords provided by Actelion:

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017