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NCT00396097 · ClinicalTrials.gov registry record · Phase 3
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
NCT00396097 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 316 participants.
The verdict
NCT00396097, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
Study Summary
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment
Interventions
- DRUG Genotropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00396097
The ClinicalTrials.gov registry entry for NCT00396097 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Genotropin is the first listed.
NCT00396097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00396097 about?
NCT00396097 is a clinical study titled "Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature". To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency o...
What is the current status of trial NCT00396097?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2006-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00396097?
The interventions under investigation include: Genotropin (DRUG).
Who is sponsoring clinical trial NCT00396097?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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