Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

AMB114588 - 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-7jcvv4

Enrollment

Unknown

Registered

2016-10-19

Start date

2011-06-21

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Interventions

Low dose group: 33 patients globally and 3 patients in Brazil receiving Ambrisentan, dose 2.5mg to 5mg according to body weight, once daily, every day for up to 10 years High dose group: 33 patients

Drug

N02.421.668.438

Eligibility

Age

8 Years to 18 Years

Inclusion criteria

Inclusion criteria: Volunteers who participated in the study AMB112529; with diagnosis of Persistent Pulmonary Arterial Hypertension; Male or female;

Exclusion criteria

Exclusion criteria: Subjects who were withdrawn from ambrisentan in Study AMB112529;subjects with severe renal impairment;

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of Ambrisentan in the proposed paediatric Pulmonary Arterial Hypertension population, safety and tolerability wil be assessed by a comparison between two ambrisentan dose groups (low x high). The parameters that will be used are review of display of adverse events, laboratory values, vital signs and pubertal development.The exams will be perfomed during the conduction of the study.	—

Measure

Time frame

To evaluate the safety and tolerability of Ambrisentan in the proposed paediatric Pulmonary Arterial Hypertension population, safety and tolerability wil be assessed by a comparison between two ambrisentan dose groups (low x high). The parameters that will be used are review of display of adverse events, laboratory values, vital signs and pubertal development.The exams will be perfomed during the conduction of the study.

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Secondary

Measure	Time frame
Obtain supportive efficacy data on the pediatric use of ambrisentan in pulmonary arterial hypertension. The following efficacy evaluation parameters will be included: The change from baseline in the 6 minute walking distance (6MWD) test evaluated after 24 weeks of therapy; Mean changes from baseline in the 6MWD test at weeks 4, 8, 12, 16, and 20; The time to clinical worsening of PAH; The change from baseline in Subject Global Assessment to week 24 using the SF-10 health survey for children; The changes week 24; Change from baseline in plasma from baseline in WHO functional class to N-Terminal pro-B-Type Natriuretic Peptide (NT- Pro BNP)concentration at week 24.	—

Measure

Time frame

Obtain supportive efficacy data on the pediatric use of ambrisentan in pulmonary arterial hypertension. The following efficacy evaluation parameters will be included: The change from baseline in the 6 minute walking distance (6MWD) test evaluated after 24 weeks of therapy; Mean changes from baseline in the 6MWD test at weeks 4, 8, 12, 16, and 20; The time to clinical worsening of PAH; The change from baseline in Subject Global Assessment to week 24 using the SF-10 health survey for children; The changes week 24; Change from baseline in plasma from baseline in WHO functional class to N-Terminal pro-B-Type Natriuretic Peptide (NT- Pro BNP)concentration at week 24.

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Countries

Argentina, Brazil, Canada, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Russian Federation, Spain, United States

Contacts

Public ContactPesquisador Responsável - Contato Público

GlaxoSmithKline Brasil

sac.brasil@gsk.com+55 21 21416000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)