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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00238485 |
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.
Condition | Intervention | Phase |
---|---|---|
Bipolar I Disorder |
Drug: Licarbazepine |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A 52-Week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder. |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CLIC477D2302E1 |
Study First Received: | October 12, 2005 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00238485 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar I Disorder |
Pathologic Processes Disease |