An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired

• Register: EUCTR
• Last refreshed on: 21 August 2012
• Main ID: EUCTR2010-021572-29-GR
• Date of registration: 26/10/2010
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research & Development, Ltd
• Public title: An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired
• Scientific title: An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired
• Date of first enrolment: 23/11/2010
• Target sample size: 66
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021572-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Diferent dose of same IMP

Countries of recruitment

Germany, Greece, Hungary, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have participated in and complied, to the best of their ability, with the protocol for
AMB112529 and have met one of the following:
a. Completed the Week 24 visit in AMB112529;
b. Required additional targeted treatment for PAH due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in AMB112529;
c. Required reduction in dose of baseline targeted treatment for PAH after ambrisentan was added to the treatment regimen;
d. In the opinion of the investigator, continued treatment with ambrisentan is warranted.
2. A female is eligible to participate in this study, as assessed by the investigator, if she is of:
a. Non-childbearing potential (i.e., physiologically incapable of becoming
pregnant); or,
b. Child-bearing potential - has a negative pregnancy test and is not lactating and,
if sexually active, agrees to continue to use 2 reliable methods of contraception
until study completion and for at least 30 days following the last dose of study
drug
3. Subject or subject’s legal guardian is able and willing to give written informed
consent. As part of the consent, female subjects of childbearing potential will be
informed of the risk of teratogenicity and will need to be counselled in a
developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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. Subjects who were withdrawn from ambrisentan in Study AMB112529;
2. Subjects who did not comply with the protocol in Study AMB112529;
3. Female subjects who are pregnant or breastfeeding;
4. Subjects with severe renal impairment (estimated creatinine clearance <30 mL/min
assessed within the previous 45 days) at the point of transition from Study
AMB112529 into this study;
5. Subject with clinically significant fluid retention in the opinion of the investigator;
6. Subject with clinically significant anaemia in the opinion of the investigator;
7. Subjects who are to enter another clinical trial or be treated with another
investigational product after exiting Study AMB112529.


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

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension
MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
MedDRA version: 12.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension

Intervention(s)

Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AMBRISENTAN
CAS Number: 0
Current Sponsor code: GSK1325760
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: AMBRISENTAN
CAS Number: 0
Current Sponsor code: GSK1325760
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: ambrisentan
Product Code: GSK1325760
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ambrisentan
Current Sponsor code: GSK1325760
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Primary end point(s): Safety as assessed by:
•Adverse Events;
• Serious Adverse Events;
• Clinical laboratory parameters;
• Physical examination (including height, weight, body mass index / body surface
area, oxygen saturation, jugular venous pressure, liver size, and presence of
peripheral oedema and/or ascites);
• Vital Signs;
• Pubertal development (change from Study AMB112529 baseline in endocrinology
assessments every six months and at 20 years of age);
• The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to tolerability issues (e.g. adverse events).

Main Objective: The primary objective is the safety and tolerability of ambrisentan in the paediatric PAH population.

Secondary Objective: Efficacy

Secondary ID(s)

AMB114588