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NCT00351468 · ClinicalTrials.gov registry record · Phase 3
EXTEND (Eltrombopag Extended Dosing Study)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
NCT00351468 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 302 participants.
The verdict
NCT00351468, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
Study Summary
An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.
Interventions
- DRUG eltrombopag olamine (SB-497115-GR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2006-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00351468
The ClinicalTrials.gov registry entry for NCT00351468 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which eltrombopag olamine (SB-497115-GR) is the first listed.
NCT00351468 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00351468 about?
NCT00351468 is a clinical study titled "EXTEND (Eltrombopag Extended Dosing Study)". An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achie...
What is the current status of trial NCT00351468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2006-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT00351468?
The interventions under investigation include: eltrombopag olamine (SB-497115-GR) (DRUG).
Who is sponsoring clinical trial NCT00351468?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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