Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.
NCT00150449
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- Must have completed the double-blind portion of the preceding trial
- Completed any protocol specified withdrawal phase and follow-up visits.
- Patient cannot participate if they experienced a serious adverse event or a
nonserious, but medically significant adverse event during the preceding efficacy
study that was judged to be related to the study medication.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders. | |||
Official Title ICMJE | A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders | |||
Brief Summary | Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Anxiety Neuroses | |||
Intervention ICMJE | Drug: Pregabalin | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Montgomery S, Emir B, Haswell H, Prieto R. Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. Curr Med Res Opin. 2013 Oct;29(10):1223-30. doi: 10.1185/03007995.2013.820694. Epub 2013 Aug 19. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 511 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | March 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Estonia, France, Germany, Israel, Italy, Latvia, Netherlands, Poland, South Africa, Spain, Ukraine, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00150449 | |||
Other Study ID Numbers ICMJE | 1008-100 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |