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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)
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)
Secondary ID [1] 0 0
BENEFIT OL
Secondary ID [2] 0 0
AC-052-370
Universal Trial Number (UTN)
Trial acronym
BENEFIT OL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance
Timepoint [1] 0 0
Until discontinuation of study drug, up to 3.3 years
Primary outcome [2] 0 0
Change From Baseline to All Assessed Time Points in Borg Dyspnea Index
Timepoint [2] 0 0
Until discontinuation of study drug, up to 3.3 years
Primary outcome [3] 0 0
Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)
Timepoint [3] 0 0
Until discontinuation of study drug, up to 3.3 years
Primary outcome [4] 0 0
Time to Clinical Worsening up to End-of-study
Timepoint [4] 0 0
Until discontinuation of study drug, up to 3.3 years
Secondary outcome [1] 0 0
Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication
Timepoint [1] 0 0
Until discontinuation of study drug, up to 3.3 years
Secondary outcome [2] 0 0
Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation
Timepoint [2] 0 0
28 days after discontinuation of study drug, up to 3.3 years
Secondary outcome [3] 0 0
Occurrence of Liver Function Test and Hemoglobin Abnormality
Timepoint [3] 0 0
Until discontinuation of study drug, up to 3.3 years

Eligibility
Key inclusion criteria
* Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
* Signed informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any major violation of protocol AC-052-366 (NCT00313222)
* Pregnancy or breast-feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
4032 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
France
State/province [11] 0 0
Clamart
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
Germany
State/province [13] 0 0
Giessen
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Pavia
Country [18] 0 0
Italy
State/province [18] 0 0
Trieste
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nieuwegein
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridge
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
Trial website
https://clinicaltrials.gov/study/NCT00319111
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00319111