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NCT00228059 · ClinicalTrials.gov registry record · Phase 3
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT00228059 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 132 participants.
The verdict
NCT00228059, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.
Interventions
- DRUG Licarbazepine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2005-01 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00228059
The ClinicalTrials.gov registry entry for NCT00228059 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 132 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 Licarbazepine is the first listed.
NCT00228059 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00228059 about?
NCT00228059 is a clinical study titled "An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.". This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.
What is the current status of trial NCT00228059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2005-01. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00228059?
The interventions under investigation include: Licarbazepine (DRUG).
Who is sponsoring clinical trial NCT00228059?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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