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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 38 participants.
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.
Interventions
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-06-21 |
| Est. Completion | 2022-06-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01342952
The ClinicalTrials.gov registry entry for NCT01342952 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 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 1 intervention - of which Ambrisentan is the first listed.
NCT01342952 reports 0 study locations.
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.
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