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NCT00471497 · ClinicalTrials.gov registry record · Phase 3
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 846
- Enrollment target
NCT00471497 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 846 participants.
The verdict
NCT00471497, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 846 participants
- Enrollment target
Study Summary
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
Interventions
- DRUG imatinib
- DRUG nilotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 846 participants |
| Start Date | 2007-07-31 |
| Est. Completion | 2019-08-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00471497
The ClinicalTrials.gov registry entry for NCT00471497 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 846 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 2 interventions - of which imatinib is the first listed.
NCT00471497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00471497 about?
NCT00471497 is a clinical study titled "A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)". In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension pr...
What is the current status of trial NCT00471497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 846 participants. The study started on 2007-07-31. Estimated completion is 2019-08-21.
What interventions are being tested in trial NCT00471497?
The interventions under investigation include: imatinib (DRUG), nilotinib (DRUG).
Who is sponsoring clinical trial NCT00471497?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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