Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT ID: NCT00624780
Last Updated: 2021-01-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
615 participants
INTERVENTIONAL
2009-05-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Pregabalin
Pregabalin 150-300 mg given twice a day
2
Lorazepam
Lorazepam 3-4 mg given twice a day
3
Pregabalin
Pregabalin 450-600 mg given twice a day
4
Placebo
Placebo
Interventions
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Pregabalin
Pregabalin 150-300 mg given twice a day
Lorazepam
Lorazepam 3-4 mg given twice a day
Pregabalin
Pregabalin 450-600 mg given twice a day
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HAM-A score \>=18 and HAM-D (item 1) score \>=2 at screening and baseline
* Needs pharmacological treatment
Exclusion Criteria
* A history of failed treatment with a benzodiazepine
* Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
18 Years
65 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
La Plata, Buenos Aires, Argentina
Pfizer Investigational Site
Lanús, Prov. de Buenos Aires, Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
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Vienna, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
San José, , Costa Rica
Pfizer Investigational Site
San José, , Costa Rica
Pfizer Investigational Site
Rijeka, , Croatia
Pfizer Investigational Site
Split, , Croatia
Pfizer Investigational Site
Zagreb, , Croatia
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
České Budějovice, , Czechia
Pfizer Investigational Site
Litoměřice, , Czechia
Pfizer Investigational Site
Lnáře, , Czechia
Pfizer Investigational Site
Mělník, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Praha 10- Strasnice, , Czechia
Pfizer Investigational Site
Strakonice, , Czechia
Pfizer Investigational Site
Espoo, , Finland
Pfizer Investigational Site
HUS, , Finland
Pfizer Investigational Site
Joensuu, , Finland
Pfizer Investigational Site
Kuopio, , Finland
Pfizer Investigational Site
Seinäjoki, , Finland
Pfizer Investigational Site
Turku, , Finland
Pfizer Investigational Site
Athens, , Greece
Pfizer Investigational Site
Ellisbridge, Ahmedabad, India
Pfizer Investigational Site
Tirupati, Andhra Pradesh, India
Pfizer Investigational Site
Mangalore, Karnataka, India
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
Chennai, Tamil Nadu, India
Pfizer Investigational Site
Denpasar, Bali, Indonesia
Pfizer Investigational Site
Jakarta, Jakarta Selatan, Indonesia
Pfizer Investigational Site
Jakarta Selatan, Jakarta Special Capital Region, Indonesia
Pfizer Investigational Site
Surabaya, , Indonesia
Pfizer Investigational Site
Kaunas, , Lithuania
Pfizer Investigational Site
Kaunas, , Lithuania
Pfizer Investigational Site
Klaipėda, , Lithuania
Pfizer Investigational Site
Vilnius, , Lithuania
Pfizer Investigational Site
Acapulco de Juárez, Guerrero, Mexico
Pfizer Investigational Site
Zapopan, Jalisco, Mexico
Pfizer Investigational Site
Mexico City, , Mexico
Pfizer Investigational Site
Khotkovo, Moscow Region, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Belgrade, , Serbia
Pfizer Investigational Site
Kragujevac, , Serbia
Pfizer Investigational Site
Ljubljana, , Slovenia
Pfizer Investigational Site
Langreo, Principality of Asturias, Spain
Pfizer Investigational Site
Zamora, , Spain
Pfizer Investigational Site
Istanbul, , Turkey (Türkiye)
Pfizer Investigational Site
Kocaeli, , Turkey (Türkiye)
Countries
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References
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Kasper S, Iglesias-Garcia C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19.
Other Identifiers
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A0081147
Identifier Type: -
Identifier Source: org_study_id
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