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NCT00138541 · ClinicalTrials.gov registry record · Phase 3
Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
NCT00138541 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 440 participants.
The verdict
NCT00138541, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
Study Summary
This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.
Interventions
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138541
The ClinicalTrials.gov registry entry for NCT00138541 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vildagliptin is the first listed.
NCT00138541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00138541 about?
NCT00138541 is a clinical study titled "Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes". This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. Th...
What is the current status of trial NCT00138541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2004-10. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00138541?
The interventions under investigation include: vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00138541?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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