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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: Completed Phase 3 study, sponsored by Novartis.
NCT00228059 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00228059 record still lists
NCT00228059 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Licarbazepine is the first listed.
NCT00228059 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00228059's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 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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