Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension

NCT00313222 | Completed Phase 3

• 1 other identifier: AC-052-366
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

CTEPH; bosentan

Outcome Measures

Primary Outcomes (2)

• Change from Baseline to Week 16 in 6-Minute Walk Test distance

  Week 16

• Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest

  Week 16

Secondary Outcomes (2)

• Change from Baseline to Week 16 in modified NYHA functional class

  Week 16

• Time to clinical worsening

  Time to clinical worsening

Interventions

bosentan DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Related Publications (1)

• Jais 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.

  PMID: 19095129 DERIVED

MeSH Terms

Interventions

Bosentan

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: October 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 3, 2025

Record last verified: 2025-01