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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00319111
Registration number
NCT00319111
Ethics application status
Date submitted
26/04/2006
Date registered
27/04/2006
Date last updated
31/12/2012
Titles & IDs
Public title
Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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Scientific title
Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)
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Secondary ID [1]
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BENEFIT OL
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Secondary ID [2]
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AC-052-370
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Universal Trial Number (UTN)
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Trial acronym
BENEFIT OL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bosentan
Experimental: Bosentan - Open label bosentan treatment
Treatment: Drugs: bosentan
Oral bosentan
* Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
* Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance
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Assessment method [1]
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Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.
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Timepoint [1]
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Until discontinuation of study drug, up to 3.3 years
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Primary outcome [2]
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Change From Baseline to All Assessed Time Points in Borg Dyspnea Index
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Assessment method [2]
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Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 \[nothing at all\], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 \[maximum ever experienced\]).
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Timepoint [2]
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Until discontinuation of study drug, up to 3.3 years
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Primary outcome [3]
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Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)
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Assessment method [3]
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Disease severity was assessed by WHO classification of PH criteria:
Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.
Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.
Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
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Timepoint [3]
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Until discontinuation of study drug, up to 3.3 years
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Primary outcome [4]
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Time to Clinical Worsening up to End-of-study
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Assessment method [4]
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An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.
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Timepoint [4]
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Until discontinuation of study drug, up to 3.3 years
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Secondary outcome [1]
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Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication
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Assessment method [1]
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Timepoint [1]
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Until discontinuation of study drug, up to 3.3 years
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Secondary outcome [2]
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Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation
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Assessment method [2]
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Timepoint [2]
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28 days after discontinuation of study drug, up to 3.3 years
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Secondary outcome [3]
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Occurrence of Liver Function Test and Hemoglobin Abnormality
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Assessment method [3]
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Number of patients with an increase in liver aminotransferases to \>3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to =10 g/dL
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Timepoint [3]
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Until discontinuation of study drug, up to 3.3 years
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Eligibility
Key inclusion criteria
* Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
* Signed informed consent
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any major violation of protocol AC-052-366 (NCT00313222)
* Pregnancy or breast-feeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Royal Perth Hospital - Perth
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Recruitment hospital [4]
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The Prince Charles Hospital - Brisbane
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment postcode(s) [4]
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4032 - Brisbane
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Minnesota
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United States of America
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North Carolina
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Praha 2
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France
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Clamart
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France
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Lyon
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Germany
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Giessen
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Germany
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Hannover
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Germany
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Mainz
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Italy
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Bologna
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Italy
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Pavia
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Italy
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Trieste
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Netherlands
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Amsterdam
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Netherlands
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Nieuwegein
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Poland
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Warszawa
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Spain
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Barcelona
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Actelion
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
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Trial website
https://clinicaltrials.gov/study/NCT00319111
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00319111
Download to PDF