Pulmonary Arterial Hypertension MedDRA version: 16.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.0 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.0 Level: LLT Classification code 10065150 Term: Associated with pulmonary arteri
Conditions
Sponsors
GlaxoSmithKline Research & Development, Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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 Subjects who were withdrawn from ambrisentan in Study AMB112529; 2.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the safety and tolerability of ambrisentan in the paediatric PAH population.;Secondary Objective: Efficacy;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). | — |
Countries
France, Germany, Greece, Hungary, Italy, Netherlands, Spain
Outcome results
None listed