Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00233675
First received: September 27, 2005
Last updated: January 12, 2006
Last verified: September 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 27, 2005 | ||||
| Last Updated Date | January 12, 2006 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00233675 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder | ||||
| Official Title ICMJE | A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety of GABITRIL at Dosages Up to 16mg/Day in Adults With Generalized Anxiety Disorder | ||||
| Brief Summary | To assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (GAD). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | General Anxiety Disorder | ||||
| Intervention ICMJE | Drug: GABITRIL (tiagabine hydrochloride; CEP-6671) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Not Provided | ||||
| Gender | Not Provided | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00233675 | ||||
| Other Study ID Numbers ICMJE | C6671A/301/AX/US | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Cephalon | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cephalon | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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