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 (AMB114588)
- Conditions
- Pulmonary Arterial HypertensionPulmonary Hypertension10037454
- Registration Number
- NL-OMON34600
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 5
* Participation 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.
* Females of childbearing potential: reliable method of contraception.
* Withdrawn from ambrisentan and/or non-compliance in study AMB112529
* Estimated creatinine clearance <30 mL/min.
* Clinically significant fluid retention.
* Clinically significant anaemia.
* Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>E.g. all cause mortality, exercise tolerance, time to clinical worsening, NT<br /><br>proBNP, NYHA class, SF-10 questionnaire.</p><br>