Last updated: 09/20/2026 15:52:08
A Study of Ambrisentan for the Treatment of Pulmonary Arterial Hypertension (PAH) in Children from 4 up to 8 Years of Age
GSK study ID
316825
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Safety, Pharmacodynamic Effects and Dosing Considerations with Ambrisentan for the Treatment of Pulmonary Arterial Hypertension in Children from 4 up to 8 Years of Age
Trial description: This is a retrospective real-world data analysis aimed at evaluating the treatment experience and dosing considerations of ambrisentan in 24 children aged 4 to less than (<) 8 years with pulmonary arterial hypertension who received ambrisentan between February 2010 and April 2023 from two United States institutions.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean Initial Dose of Ambrisentan
Timeframe: At ambrisentan initiation
Mean Duration of Follow-up
Timeframe: From ambrisentan initiation up to 12.2 years
Secondary outcomes:
Number of Participants Hospitalized for Worsening PAH
Timeframe: From ambrisentan initiation up to 12.2 years
Number of Participants Who Had Prostanoids Added
Timeframe: From ambrisentan initiation up to 12.2 years
Number of Participants Requiring Surgical Interventions
Timeframe: From ambrisentan initiation up to 12.2 years
Number of Participants Who Died
Timeframe: From ambrisentan initiation up to 12.2 years
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2024-14-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
May 2023 to August 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
4 - 7 Years
Accepts healthy volunteers
No
- Male or female participants from 4 years of age to < 8 years of age at the time when ambrisentan was initiated
- Diagnosis of PAH (6th World Symposium on Pulmonary Hypertension Group 1)
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female participants from 4 years of age to < 8 years of age at the time when ambrisentan was initiated
- Diagnosis of PAH (6th World Symposium on Pulmonary Hypertension Group 1)
- Participant was receiving ambrisentan along with phosphodiesterase-5 (PDE5) inhibitor combination treatment with or without additional medications for PAH between February 2010 and April 2023
- Informed consent was obtained through the Colorado Multiple Institution Review Board (05-0551) or Columbia University Institutional Review Board (AAAK2059)
Exclusion criteria:
- Not applicable.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2024-14-08
Actual study completion date
2024-14-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website