Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00313222
Other study ID # AC-052-366
Secondary ID
Status Completed
Phase Phase 3
First received April 10, 2006
Last updated February 11, 2010
Start date October 2005
Est. completion date March 2007

Study information

Verified date February 2010
Source Actelion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date March 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
bosentan


Locations

Country Name City State
Australia The Prince Charles Hospital Brisbane
Australia St. Vincent's Hospital Darlinghurst New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia Royal Perth Hospital Perth Western Australia
Austria General Hospital of Vienna Vienna
Belgium University Hospital Erasme Brussels
Belgium University Hospital Gathuisberg Leuven
Canada The Ottawa Hospital Ottawa Ontario
Canada Centre de Pneumonologie de L'Hospital Laval Sainte-Foy Quebec
Canada University of Western Ontario Sainte-Foy Quebec
Canada Toronto General Hospital Pulmonary & Critical Care Medicine Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia
Czech Republic Charles University, Internal Medicine Department, (PAH unit) Praha 2
France Hopital Cardiologique Louis-Pradel Bron Cedex
France Hopital Antoinw Beclere Clamart
Germany University Hospital Giessen Giessen
Germany Medizinische Hochschule Hannover Hannover
Germany Johannes Gutenberg University Hospital Mainz
Italy Policlinico S. Orsola-Malpighi Bologna
Italy Azienda Ospedailera San Luigi Orbassano
Italy San Matteo Hospital Pavia
Italy Ospedale di Cattinara Trieste
Netherlands Academic Medical Center Amsterdam
Netherlands St. Antonius Ziekennuis Nieuwegein
Poland Medical University of Warsaw Warszawa
Spain Hospital Clinico i Provincial Barcelona
United Kingdom Papworth Hospital Cambridge
United Kingdom Western Infirmary Glasgow
United States Duke University Medical Center Durham North Carolina
United States University of California at San Diego LaJolla California
United States Mayo Clinic, Division of Cardiovascular Diseases and Internal Medicine Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 16 in 6-Minute Walk Test distance Week 16
Primary Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest Week 16
Secondary Change from Baseline to Week 16 in modified NYHA functional class Week 16
Secondary Time to clinical worsening Time to clinical worsening
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Active, not recruiting NCT06003244 - High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT) N/A
Active, not recruiting NCT06072417 - HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level) N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Recruiting NCT02061787 - the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
Not yet recruiting NCT03102294 - Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension N/A
Recruiting NCT04071327 - Pulmonary Hypertension Association Registry
Recruiting NCT05311072 - Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Database in China
Recruiting NCT05340023 - Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
Enrolling by invitation NCT05568927 - Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
Completed NCT03786367 - Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
Recruiting NCT04081012 - N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension. N/A
Not yet recruiting NCT06384534 - Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) N/A
Withdrawn NCT05693779 - Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension N/A
Not yet recruiting NCT02426203 - 3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy N/A
Completed NCT02094001 - Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH Phase 2
Enrolling by invitation NCT03388476 - Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
Recruiting NCT04206852 - Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Completed NCT02111980 - RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators N/A
Enrolling by invitation NCT05618093 - Non-Invasive Measurement of Cardiac Output and Stroke Volume in PAH/CTEPH N/A