Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01342952
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2011-04-26
Brief Title:
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open label long term extension to Study AMB112529 All subjects may remain in the extension study for a minimum of six months Beyond the six month period subjects may continue in the extension study until one of the following conditions is met
the subject turns 18 years of age when the subject can receive marketed product the product is approved and available for use in the subjects age group development for use in the paediatric population is discontinued the subject decides heshe no longer wants to participate in the study the investigator considers it is in the best interest of the subject to discontinue ambrisentan eg for safety reasons
The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters
the subject turns 18 years of age when the subject can receive marketed product the product is approved and available for use in the subjects age group development for use in the paediatric population is discontinued the subject decides heshe no longer wants to participate in the study the investigator considers it is in the best interest of the subject to discontinue ambrisentan eg for safety reasons
The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters
Detailed Description:
Pulmonary arterial hypertension PAH is a rare progressive highly debilitating disease characterized by vascular obstruction and the variable presence of vasoconstriction leading to increased pulmonary vascular resistance and right-sided heart failure If left untreated PAH ultimately leads to right ventricular failure and death adult subjects have a median survival of 28 years without treatment Epidemiological estimates vary but prevalence in Europe is thought to be of the order of 15 cases per million Large scale epidemiology studies of PAH in children have not been conducted and there is no or limited outcome data in paediatric PAH patients A register in France 1995-1996 estimates the prevalence in children is as low as 37 cases per million In a national comprehensive country wide survey of the epidemiology of idiopathic PAH IPAH management and survival in the United Kingdom UK the incidence was 048 cases per million children per year and the prevalence was 21 cases per million children
Ambrisentan VOLIBRIS tablets is an endothelin receptor antagonist ERA marketed in the European Union EU and some other countries by GlaxoSmithKline GSK and in the United States as LETAIRIS by Gilead Sciences Inc Ambrisentan is indicated for the treatment of adult patients with PAH to improve exercise capacity decrease the symptoms of PAH and delay clinical worsening
The primary purpose of this long term paediatric study is to provide clinically relevant information on the long term safety of ambrisentan in children with the most common causes of PAH in this age group This study is only open to patients who have participated in Study AMB112529 A randomized open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan adjusted for body weight for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years and in whom continued treatment with ambrisentan is warranted
This study is part of a Paediatric Investigational Plan PIP EMEA-000434-PIP01-08 agreed with the European Medicines Agencys Paediatric Committee PDCO
Ambrisentan VOLIBRIS tablets is an endothelin receptor antagonist ERA marketed in the European Union EU and some other countries by GlaxoSmithKline GSK and in the United States as LETAIRIS by Gilead Sciences Inc Ambrisentan is indicated for the treatment of adult patients with PAH to improve exercise capacity decrease the symptoms of PAH and delay clinical worsening
The primary purpose of this long term paediatric study is to provide clinically relevant information on the long term safety of ambrisentan in children with the most common causes of PAH in this age group This study is only open to patients who have participated in Study AMB112529 A randomized open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan adjusted for body weight for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years and in whom continued treatment with ambrisentan is warranted
This study is part of a Paediatric Investigational Plan PIP EMEA-000434-PIP01-08 agreed with the European Medicines Agencys Paediatric Committee PDCO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-021572-29 | EUDRACT_NUMBER | None | None |