A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.

• Register: EUCTR
• Last refreshed on: 2 June 2014
• Main ID: EUCTR2011-004612-31-PT
• Date of registration: 02/05/2012
• Prospective Registration: Yes
• Primary sponsor: Actelion pharmaceuticals Ltd
• Public title: A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.
• Scientific title: A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6
• Date of first enrolment: 06/07/2012
• Target sample size: 105
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004612-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Argentina, Bulgaria, Chile, China, Colombia, Croatia, France, Guatemala, India, Malaysia, Mexico, Netherlands, Peru, Philippines, Portugal, Russian Federation, Serbia, Singapore, South Africa, Taiwan, Ukraine, United States, Vietnam

Contacts

• Name: GLOBAL MEDICAL INFORMATION
• Affiliation: Actelion Pharmaceuticals Ltd.

• Name: GLOBAL MEDICAL INFORMATION
• Affiliation: Actelion Pharmaceuticals Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent by the parents / legal representatives prior to any study-mandated procedure.

2. Patients who:
- were treated for 12 weeks in FUTURE 5
Or
- discontinued FUTURE 5 due to PAH-progression.

And who performed the Visit 5 assessments of FUTURE 5 according to the FUTURE 5 protocol.

3. Patients who did not prematurely discontinue the study drug due to AEs in FUTURE 5.

4. Females of childbearing potential must have a negative pre treatment serum pregnancy test and must use reliable methods of contraception during the whole treatment period and for 1 month after study drug discontinuation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 105
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the bosentan dispersible tablet.

2. Pregnancy or breastfeeding.

3. Any AST and/or ALT values > 3 times the upper limit of normal range (ULN) until Visit 5 of FUTURE 5 (inclusive).

4. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C until Visit 5 of FUTURE 5 (inclusive).

5. Any condition that prevents compliance with FUTURE 6 protocol or adherence to therapy.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Tracleer
Product Name: bosentan
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: bosentan
CAS Number: 157212-55-0
Current Sponsor code: ACT-050088
Other descriptive name: BOSENTAN MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32-

Primary Outcome(s)

Main Objective: To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).

Primary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary Objective: Not Applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

AC-052-376

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd.