An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1

• Register: EUCTR
• Last refreshed on: 3 February 2014
• Main ID: EUCTR2005-001967-70-IT
• Date of registration: 19/01/2007
• Prospective Registration: No
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1
• Scientific title: An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1
• Date of first enrolment: 20/10/2005
• Target sample size: 35
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001967-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Germany, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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:


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

Health Condition(s) or Problem(s) studied

Treatment of pulmonary arterial hypertension in children
MedDRA version: 14.1 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 100000004855

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

Intervention(s)

Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Bosentan
Concentration unit: mg milligram(s)
Concentration number: 32-

Primary Outcome(s)

Secondary Objective:

Main Objective:

Primary end point(s):

Secondary ID(s)

2005-001967-70-GB

AC-052-367