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NCT01332331 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Ambrisentan in Children 8-18yrs
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT01332331: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT01332331 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332331, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.
Primary Outcome
AEs defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, medical events that may no
Interventions
- DRUG Ambrisentan - low dose
- DRUG Ambrisentan - high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-01-04 |
| Est. Completion | 2013-11-12 |
| Phase | Phase 2 |
Why NCT01332331 stopped before completion
NCT01332331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Ambrisentan - low dose is the first listed.
NCT01332331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01332331 about?
NCT01332331 is a clinical study titled "Efficacy and Safety of Ambrisentan in Children 8-18yrs". A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine t...
What is the current status of trial NCT01332331?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2011-01-04. Estimated completion is 2013-11-12.
What interventions are being tested in trial NCT01332331?
The interventions under investigation include: Ambrisentan - low dose (DRUG), Ambrisentan - high dose (DRUG).
Who is sponsoring clinical trial NCT01332331?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01332331's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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