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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 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01332331
The ClinicalTrials.gov registry entry for NCT01332331 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ambrisentan - low dose is the first listed.
NCT01332331 reports 0 study locations.
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.
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