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NCT01342952 · ClinicalTrials.gov registry record · Phase 2
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01342952: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01342952 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342952, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study 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 subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. 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.
Primary Outcome
AE was defined as any untoward medical occurrence in participant or clinical investigation participant,temporally associated with use of medicinal product, whether or not considered related to medicinal product.SAE was 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 congenital anomaly or birth defect, important medical events that may
Interventions
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2022-06-09 |
| Phase | Phase 2 |
What the finished NCT01342952 record still lists
NCT01342952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Ambrisentan is the first listed.
NCT01342952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01342952 about?
NCT01342952 is a clinical study titled "Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529". 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 subj...
What is the current status of trial NCT01342952?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2011-06-21. Estimated completion is 2022-06-09.
What interventions are being tested in trial NCT01342952?
The interventions under investigation include: Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT01342952?
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 NCT01342952's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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