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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following 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 (reliable methods of contraception are listed in Appendix 2).
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

Subjects meeting any of the following criteria must not be enrolled in the study:
1.Subjects who were withdrawn from ambrisentan in Study AMB112529;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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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GlaxoSmithKline Research & Development, Ltd

Updated 8/21/2012