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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01338415




Registration number
NCT01338415
Ethics application status
Date submitted
15/04/2011
Date registered
19/04/2011
Date last updated
21/07/2020

Titles & IDs
Public title
FUTURE 3 Study Extension
Scientific title
A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
2010-021793-12
Secondary ID [2] 0 0
AC-052-374
Universal Trial Number (UTN)
Trial acronym
FUTURE 3 Ext
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bosentan

Experimental: bosentan 2mg/kg b.i.d. - Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study

Experimental: bosentan 2mg/kg t.i.d. - Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study


Treatment: Drugs: Bosentan
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation - This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study.
NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
Timepoint [1] 0 0
Up to 62 weeks in average

Eligibility
Key inclusion criteria
1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely
discontinued due to PAH-progression, if bosentan was not permanently discontinued

2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is
considered beneficial at the end of the FUTURE 3 core study (AC-052-373)

3. Signed informed consent by the parents or the legal representatives prior to any
study-mandated procedure.
Minimum age
3 Months
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible bosentan tablet

2. Any clinically significant laboratory abnormality that precludes continuation of
bosentan therapy

3. Pregnancy

4. AST and/or ALT values > 3 times the upper limit of normal range (ULN)

5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C

6. Premature and permanent study drug discontinuation during the FUTURE 3 core study
(AC-052-373)

7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.

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
Parallel
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne, Cardiology - Site 5001 - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Bonn
Country [12] 0 0
Germany
State/province [12] 0 0
Giessen
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Szeged
Country [15] 0 0
India
State/province [15] 0 0
Hyderabad
Country [16] 0 0
Israel
State/province [16] 0 0
Petach Tikvah
Country [17] 0 0
Italy
State/province [17] 0 0
Padova
Country [18] 0 0
Italy
State/province [18] 0 0
Rome
Country [19] 0 0
Mexico
State/province [19] 0 0
Mexico City
Country [20] 0 0
Poland
State/province [20] 0 0
Gdansk
Country [21] 0 0
Poland
State/province [21] 0 0
Wroclaw
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Kemerovo
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Moscow
Country [24] 0 0
Russian Federation
State/province [24] 0 0
St. Petersberg
Country [25] 0 0
Russian Federation
State/province [25] 0 0
St. Petersburg
Country [26] 0 0
Serbia
State/province [26] 0 0
Belgrade
Country [27] 0 0
South Africa
State/province [27] 0 0
Bloemfontein
Country [28] 0 0
South Africa
State/province [28] 0 0
Pretoria
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Ukraine
State/province [31] 0 0
Dnepropetrovsk
Country [32] 0 0
Ukraine
State/province [32] 0 0
Donetsk
Country [33] 0 0
Ukraine
State/province [33] 0 0
Kiev

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

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,
tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
day in children with Pulmonary Arterial Hypertension (PAH).
Trial website
https://clinicaltrials.gov/show/NCT01338415
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
Other publications