Clinical trial NCT00150449: Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.
Official title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Neuroses
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.


Eligibility criteria: Inclusion Criteria:

* Must have completed the double-blind portion of the preceding trial
* Completed any protocol specified withdrawal phase and follow-up visits.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: A-1040 Wien
country: Austria
facility: Pfizer Investigational Site
city: Wein
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: De Pinte
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Kortrijk
country: Belgium
facility: Pfizer Investigational Site
city: Lede
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Sint-Denijs-Westrem
country: Belgium
facility: Pfizer Investigational Site
city: Tielt
country: Belgium
facility: Pfizer Investigational Site
city: Tournai
country: Belgium
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Reims
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Denguin
country: France
facility: Pfizer Investigational Site
city: Elancourt
country: France
facility: Pfizer Investigational Site
city: Metz
country: France
facility: Pfizer Investigational Site
city: Montesson
country: France
facility: Pfizer Investigational Site
city: Montigny les Metz
country: France
facility: Pfizer Investigational Site
city: Saint Etienne du Gres
country: France
facility: Pfizer Investigational Site
city: Wasquehal
country: France
facility: Pfizer Investigational Site
city: Bad-Deurrheim
country: Germany
facility: Pfizer Investigational Site
city: Bremerhaven
country: Germany
facility: Pfizer Investigational Site
city: Gottingen
country: Germany
facility: Pfizer Investigational Site
city: Gottingen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Kothen
country: Germany
facility: Pfizer Investigational Site
city: Lauf
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Osnabrueck
country: Germany
facility: Pfizer Investigational Site
city: Siegen
country: Germany
facility: Pfizer Investigational Site
city: Spaichingen
country: Germany
facility: Pfizer Investigational Site
city: Ness Ziona
country: Israel
facility: Pfizer Investigational Site
city: Bassano del Grappa (Vicenza)
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Ambacht
country: Netherlands
facility: Pfizer Investigational Site
city: BV Losser
country: Netherlands
facility: Pfizer Investigational Site
city: GC Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Hoogvliet
country: Netherlands
facility: Pfizer Investigational Site
city: Huizen
country: Netherlands
facility: Pfizer Investigational Site
city: Losser
country: Netherlands
facility: Pfizer Investigational Site
city: RC Dordrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwigndrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwijndreacht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Katowice
country: Poland
facility: Pfizer Investigational Site
city: Olsztyn
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Tuszyn
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Zabrze
country: Poland
facility: Pfizer Investigational Site
city: Goodwood
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Paarl
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Kempton Park
country: South Africa
facility: Pfizer Investigational Site
state: Johannesburg
city: Rosebank
country: South Africa
facility: Pfizer Investigational Site
state: Johannesburg
city: Hatfield
country: South Africa
facility: Pfizer Investigational Site
state: Pretoria
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: East London
country: South Africa
facility: Pfizer Investigational Site
city: George
country: South Africa
facility: Pfizer Investigational Site
city: Hurlingham, Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Pietersburg
country: South Africa
facility: Pfizer Investigational Site
city: Pinetown Natal
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Sandton
country: South Africa
facility: Pfizer Investigational Site
city: Somerset West
country: South Africa
facility: Pfizer Investigational Site
city: Westville
country: South Africa
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Granollers
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Kharkov
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Maidenhead
country: United Kingdom
facility: Pfizer Investigational Site
state: Berkshire
city: Slough
country: United Kingdom
facility: Pfizer Investigational Site
state: Berks
city: Falmouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Fowey
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Saltash
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: St. Austell
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Downpatrick
country: United Kingdom
facility: Pfizer Investigational Site
state: County Down
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Derbyshire
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Bexhill-on-sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Leigh-On-Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Leslie
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: Limekilns
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: Cathcart
country: United Kingdom
facility: Pfizer Investigational Site
state: Glasgow
city: Clarckston
country: United Kingdom
facility: Pfizer Investigational Site
state: Glasgow
city: Rutherglen
country: United Kingdom
facility: Pfizer Investigational Site
state: Glasgow
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Chelsea
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Bangor
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Greenisland, Carrickfergus
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Houston
country: United Kingdom
facility: Pfizer Investigational Site
state: Renfrewshire
city: Epworth, Doncaster
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: St. John's, Woking
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Trowbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Inkberrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Worcestershire
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
city: Cookstown
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Earlsdon, Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Port Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Rugby
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.