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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00351468 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.
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 |
What the finished NCT00351468 record still lists
NCT00351468 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which eltrombopag olamine (SB-497115-GR) is the first listed.
NCT00351468 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00351468's enrollment target sits among peer trials
302 1119th of 2000 higher than 880 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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