Bipolar Disorder Clinical Trial
Official title:
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
Verified date | March 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
Status | Completed |
Enrollment | 181 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - written informed consent provided prior to participation in the extension study - successful completion of study CLIC477D2303 - cooperation and willingness to comply with all study requirements Exclusion Criteria: - premature discontinuation from study CLIC477D2303 - failure to comply with study CLIC477D2303 |
Country | Name | City | State |
---|---|---|---|
Austria | Novartis Investigational Site | Vienna | |
Canada | Novartis Investigational Site | Kelowna | |
Canada | Novartis Investigational Site | London | |
Canada | Novartis Investigational Site | Montreal | |
Canada | Novartis Investigational Site | Sudbury | |
Canada | Novartis Investigator Site | Vancouver | |
Colombia | Novartis Investigational Site | Bogota | |
Colombia | Novartis Investigational Site | Medellin | |
Colombia | Novartis Investigational Site | Pareira | |
Czech Republic | Novartis Investigational Site | Brno | |
Czech Republic | Novartis Investigational Site | Hradec Kralove | |
Czech Republic | Novartis Investigational Site | Prague | |
Germany | Novartis Investigational Site | Berlin | |
Germany | Novartis Investigational Site | Bochum | |
Germany | Novartis Investigational Site | Dresden | |
Germany | Novartis Investigational Site | Ingolstadt | |
Germany | Novartis Investigational Site | Mannheim | |
Germany | Novartis Investigational Site | Wurzburg | |
Guatemala | Novartis Investigational Site | Guatemala City | |
Peru | Novartis Investigational Site | Lima | |
Russian Federation | Novartis Investigational Site | Moscow | |
Russian Federation | Novartis Investigational Site | Yaroslavl | |
Slovakia | Novartis Investigational Site | Bojnice | |
Slovakia | Novartis Investigational Site | Michalovce | |
South Africa | Novartis Investigational Site | Durban | |
Ukraine | Novartis Investigational Site | Dnepropetrovsk | |
Ukraine | Novartis Investigational Site | Kiev | |
Ukraine | Novartis Investigational Site | Lugansk | |
Ukraine | Novartis Investigational Site | Odessa | |
Ukraine | Novartis Investigational Site | Simferopol | |
United States | Novartis Investigational Site | Bellaire | Texas |
United States | Novartis Investigational Site | Bellevue | Washington |
United States | Novartis Investigational Site | Dallas | Texas |
United States | Novartis Investigational Site | Farmington Hills | Michigan |
United States | Novartis Investigational Site | Kansas City | Kansas |
United States | Novartis Investigational Site | Kirkland | Washington |
United States | Investigational site | La Palma | California |
United States | Novartis Investigational Site | Madison | Tennessee |
United States | Novartis Investigational Site | Shreveport | Louisiana |
United States | Novartis Investigational Site | Somerville | Massachusetts |
United States | Novartis Investigational Site | Staten Island | New York |
United States | Novartis Investigational Site | Verdun | Texas |
United States | Novartis Investigational site | West Allis | Wisconsin |
Venezuela | Novartis Investigational Site | Caracas |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, Venezuela, Austria, Canada, Colombia, Czech Republic, Germany, Guatemala, Peru, Russian Federation, Slovakia, South Africa, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of treatment with licarbazepine over 52 weeks. | |||
Primary | with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs. |
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