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Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00313222
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Actelion

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date February 15, 2010
Study Start Date  ICMJE October 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
  • Change from Baseline to Week 16 in 6-Minute Walk Test distance
  • Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
  • Change from Baseline to Week 16 in modified NYHA functional class
  • Time to clinical worsening
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Thromboembolic Pulmonary Hypertension
Intervention  ICMJE Drug: bosentan
Study Arms  ICMJE Not Provided
Publications * Jaïs X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2007)
157
Original Enrollment  ICMJE
 (submitted: April 10, 2006)
130
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313222
Other Study ID Numbers  ICMJE AC-052-366
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sebastien Roux, MD, Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Actelion
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP