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Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

Primary Purpose

Anxiety Neuroses

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Neuroses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Safety Tolerability

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
July 13, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00150449
Brief Title
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

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Neuroses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
511 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Safety Tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
A-1040 Wien
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wein
ZIP/Postal Code
A-1020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1050
Country
Austria
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
De Pinte
ZIP/Postal Code
9840
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Lede
ZIP/Postal Code
9340
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Sint-Denijs-Westrem
ZIP/Postal Code
9051
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tielt
ZIP/Postal Code
8700
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Reims
State/Province
Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Pfizer Investigational Site
City
Denguin
ZIP/Postal Code
64230
Country
France
Facility Name
Pfizer Investigational Site
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
Pfizer Investigational Site
City
Metz
ZIP/Postal Code
F-57000
Country
France
Facility Name
Pfizer Investigational Site
City
Montesson
ZIP/Postal Code
78360
Country
France
Facility Name
Pfizer Investigational Site
City
Montigny les Metz
ZIP/Postal Code
57950
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Etienne du Gres
ZIP/Postal Code
13103
Country
France
Facility Name
Pfizer Investigational Site
City
Wasquehal
ZIP/Postal Code
59290
Country
France
Facility Name
Pfizer Investigational Site
City
Bad-Deurrheim
ZIP/Postal Code
78073
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bremerhaven
ZIP/Postal Code
27568
Country
Germany
Facility Name
Pfizer Investigational Site
City
Gottingen
ZIP/Postal Code
D-37073
Country
Germany
Facility Name
Pfizer Investigational Site
City
Gottingen
ZIP/Postal Code
D-37085
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
D-22767
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kothen
ZIP/Postal Code
D-06366
Country
Germany
Facility Name
Pfizer Investigational Site
City
Lauf
ZIP/Postal Code
77886
Country
Germany
Facility Name
Pfizer Investigational Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Pfizer Investigational Site
City
Osnabrueck
ZIP/Postal Code
49078
Country
Germany
Facility Name
Pfizer Investigational Site
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Pfizer Investigational Site
City
Spaichingen
ZIP/Postal Code
78549
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ness Ziona
ZIP/Postal Code
70450
Country
Israel
Facility Name
Pfizer Investigational Site
City
Bassano del Grappa (Vicenza)
ZIP/Postal Code
36061
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Riga
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Ambacht
ZIP/Postal Code
3341 CS HI
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
BV Losser
ZIP/Postal Code
7581
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
GC Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hoogvliet
ZIP/Postal Code
3192 JN
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Huizen
ZIP/Postal Code
1271 BB
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Losser
ZIP/Postal Code
7581 BV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
RC Dordrecht
ZIP/Postal Code
3317
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwigndrecht
ZIP/Postal Code
3333 EP
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwijndreacht
ZIP/Postal Code
3334 XA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3331 AE
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3332 AJ
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Netherlands
Facility Name
Pfizer Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3335 EJ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bialystok
ZIP/Postal Code
15-420
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
Facility Name
Pfizer Investigational Site
City
Katowice
ZIP/Postal Code
40-635
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Poland
Facility Name
Pfizer Investigational Site
City
Olsztyn
ZIP/Postal Code
10-511
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Poland
Facility Name
Pfizer Investigational Site
City
Torun
ZIP/Postal Code
87-100
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Poland
Facility Name
Pfizer Investigational Site
City
Tuszyn
ZIP/Postal Code
95-080
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Poland
Facility Name
Pfizer Investigational Site
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Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-229
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Pfizer Investigational Site
City
Goodwood
State/Province
Cape Town
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Paarl
State/Province
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Kempton Park
State/Province
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Rosebank
State/Province
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Hatfield
State/Province
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Pfizer Investigational Site
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Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Pfizer Investigational Site
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Bloemfontein
ZIP/Postal Code
9301
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South Africa
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Pfizer Investigational Site
City
Bloemfontein
ZIP/Postal Code
9330
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South Africa
Facility Name
Pfizer Investigational Site
City
East London
ZIP/Postal Code
5201
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South Africa
Facility Name
Pfizer Investigational Site
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George
ZIP/Postal Code
6529
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South Africa
Facility Name
Pfizer Investigational Site
City
Hurlingham, Johannesburg
ZIP/Postal Code
2070
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South Africa
Facility Name
Pfizer Investigational Site
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Pietersburg
ZIP/Postal Code
0699
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pinetown Natal
ZIP/Postal Code
3610
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South Africa
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Pfizer Investigational Site
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Pretoria
ZIP/Postal Code
0002
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South Africa
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Pfizer Investigational Site
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Pretoria
ZIP/Postal Code
0181
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South Africa
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Pfizer Investigational Site
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Sandton
ZIP/Postal Code
2196
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South Africa
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Pfizer Investigational Site
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Somerset West
ZIP/Postal Code
7130
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South Africa
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Pfizer Investigational Site
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Westville
ZIP/Postal Code
3630
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South Africa
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Pfizer Investigational Site
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Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
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Spain
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Pfizer Investigational Site
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Granollers
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Barcelona
ZIP/Postal Code
08400
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Spain
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Pfizer Investigational Site
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Barcelona
ZIP/Postal Code
08036
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Spain
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Pfizer Investigational Site
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Barcelona
ZIP/Postal Code
08100
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Spain
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Pfizer Investigational Site
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Madrid
ZIP/Postal Code
28006
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Spain
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Pfizer Investigational Site
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Madrid
ZIP/Postal Code
28009
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Spain
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Pfizer Investigational Site
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Madrid
ZIP/Postal Code
28037
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Spain
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Pfizer Investigational Site
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Madrid
ZIP/Postal Code
28041
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Spain
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Pfizer Investigational Site
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Pamplona
ZIP/Postal Code
31014
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Spain
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Pfizer Investigational Site
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Sevilla
ZIP/Postal Code
41700
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Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50007
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Spain
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Pfizer Investigational Site
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65006
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Ukraine
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Pfizer Investigational Site
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Maidenhead
State/Province
Berkshire
ZIP/Postal Code
SL6 2LH
Country
United Kingdom
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Pfizer Investigational Site
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Slough
State/Province
Berks
ZIP/Postal Code
SL2 1HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Falmouth
State/Province
Cornwall
ZIP/Postal Code
TR11 2LH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR18 4JH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Saltash
State/Province
Cornwall
ZIP/Postal Code
PL12 6DL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St. Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Downpatrick
State/Province
County Down
ZIP/Postal Code
BT30 6HY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 7TH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bexhill on Sea
State/Province
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bexhill-on-sea
State/Province
East Sussex
ZIP/Postal Code
TN40 1HE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leigh-On-Sea
State/Province
Essex
ZIP/Postal Code
SS3 2SQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leslie
State/Province
Fife
ZIP/Postal Code
KY6 3LQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Limekilns
State/Province
Fife
ZIP/Postal Code
KY11 3HS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cathcart
State/Province
Glasgow
ZIP/Postal Code
G44 3DH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Clarckston
State/Province
Glasgow
ZIP/Postal Code
G76 7BX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Rutherglen
State/Province
Glasgow
ZIP/Postal Code
G73 2PQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
State/Province
Lancashire
ZIP/Postal Code
BL1 6AF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chelsea
State/Province
London
ZIP/Postal Code
SW3 4BP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bangor
State/Province
Northern Ireland
ZIP/Postal Code
BT19 1PP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenisland, Carrickfergus
State/Province
Northern Ireland
ZIP/Postal Code
BT38 8TP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Renfrewshire
ZIP/Postal Code
PA6 7AR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Epworth, Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN9 1EP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St. John's, Woking
State/Province
Surrey
ZIP/Postal Code
GU21 ITD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
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Trowbridge
State/Province
Wiltshire
ZIP/Postal Code
BA14 8QA
Country
United Kingdom
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Pfizer Investigational Site
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Inkberrow
State/Province
Worcestershire
ZIP/Postal Code
WR7 4ED
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B37 7TR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
ZIP/Postal Code
BL4 9QZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
ZIP/Postal Code
BL6 7AN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
ZIP/Postal Code
S40 1LE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cookstown
ZIP/Postal Code
BT80 8BN
Country
United Kingdom
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Pfizer Investigational Site
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Coventry
ZIP/Postal Code
CV12 OHU
Country
United Kingdom
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Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV2 1SG
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United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 5LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Earlsdon, Coventry
ZIP/Postal Code
CV5 6EU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G3 8YJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G41 3YE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G69 7AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS12 ITZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Port Glasgow
ZIP/Postal Code
PA14 6HW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Rugby
ZIP/Postal Code
CV21 3SP
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Citations:
PubMed Identifier
23808960
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=1008-100&StudyName=Determine+Long%2DTerm+Safety+and+Tolerability+of+Pregabalin+in+Patients+with+Anxiety+Disorders%2E
Description
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Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

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