Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.
A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders
1 other identifier
interventional
511
13 countries
126
Brief Summary
Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2001
Longer than P75 for phase_3
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJuly 14, 2006
July 1, 2006
September 6, 2005
July 13, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Safety Tolerability
Interventions
Eligibility Criteria
You may qualify if:
- Must have completed the double-blind portion of the preceding trial
- Completed any protocol specified withdrawal phase and follow-up visits.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (138)
Pfizer Investigational Site
A-1040 Wien, Austria
Pfizer Investigational Site
Vienna, A-1050, Austria
Pfizer Investigational Site
Wein, A-1020, Austria
Pfizer Investigational Site
Brussels, 1020, Belgium
Pfizer Investigational Site
De Pinte, 9840, Belgium
Pfizer Investigational Site
Ghent, 9000, Belgium
Pfizer Investigational Site
Kortrijk, 8500, Belgium
Pfizer Investigational Site
Lede, 9340, Belgium
Pfizer Investigational Site
Liège, B-4000, Belgium
Pfizer Investigational Site
Sint-Denijs-Westrem, 9051, Belgium
Pfizer Investigational Site
Tielt, 8700, Belgium
Pfizer Investigational Site
Tournai, 7500, Belgium
Pfizer Investigational Site
Tallinn, 10614, Estonia
Pfizer Investigational Site
Tartu, 50417, Estonia
Pfizer Investigational Site
Reims, Cedex, 51092, France
Pfizer Investigational Site
Denguin, 64230, France
Pfizer Investigational Site
Élancourt, 78990, France
Pfizer Investigational Site
Metz, F-57000, France
Pfizer Investigational Site
Montesson, 78360, France
Pfizer Investigational Site
Montigny-lès-Metz, 57950, France
Pfizer Investigational Site
Saint-Étienne-du-Grès, 13103, France
Pfizer Investigational Site
Wasquehal, 59290, France
Pfizer Investigational Site
Bad-Deurrheim, 78073, Germany
Pfizer Investigational Site
Bremerhaven, 27568, Germany
Pfizer Investigational Site
Göttingen, D-37073, Germany
Pfizer Investigational Site
Göttingen, D-37085, Germany
Pfizer Investigational Site
Hamburg, D-22767, Germany
Pfizer Investigational Site
Köthen, D-06366, Germany
Pfizer Investigational Site
Lauf, 77886, Germany
Pfizer Investigational Site
Oldenburg, 26121, Germany
Pfizer Investigational Site
Osnabrück, 49078, Germany
Pfizer Investigational Site
Siegen, 57072, Germany
Pfizer Investigational Site
Spaichingen, 78549, Germany
Pfizer Investigational Site
Ness Ziona, 70450, Israel
Pfizer Investigational Site
Bassano Del Grappa (Vicenza), 36061, Italy
Pfizer Investigational Site
Bologna, 40123, Italy
Pfizer Investigational Site
Milan, Italy
Pfizer Investigational Site
Roma, 00122, Italy
Pfizer Investigational Site
Riga, Latvia
Pfizer Investigational Site
BV Losser, 7581, Netherlands
Pfizer Investigational Site
GC Nijmegen, 6525, Netherlands
Pfizer Investigational Site
Hoogvliet, 3192 JN, Netherlands
Pfizer Investigational Site
Huizen, 1271 BB, Netherlands
Pfizer Investigational Site
Losser, 7581 BV, Netherlands
Pfizer Investigational Site
RC Dordrecht, 3317, Netherlands
Pfizer Investigational Site
Vlaardinger-Ambacht, 3341 CS HI, Netherlands
Pfizer Investigational Site
Zwigndrecht, 3333 EP, Netherlands
Pfizer Investigational Site
Zwijndreacht, 3334 XA, Netherlands
Pfizer Investigational Site
Zwijndrecht, 3331 AE, Netherlands
Pfizer Investigational Site
Zwijndrecht, 3332 AJ, Netherlands
Pfizer Investigational Site
Zwijndrecht, 3335 EJ, Netherlands
Pfizer Investigational Site
Bialystok, 15-420, Poland
Pfizer Investigational Site
Bydgoszcz, 85-096, Poland
Pfizer Investigational Site
Katowice, 40-635, Poland
Pfizer Investigational Site
Olsztyn, 10-511, Poland
Pfizer Investigational Site
Torun, 87-100, Poland
Pfizer Investigational Site
Tuszyn, 95-080, Poland
Pfizer Investigational Site
Warsaw, 02-957, Poland
Pfizer Investigational Site
Wroclaw, 50-229, Poland
Pfizer Investigational Site
Zabrze, 41-800, Poland
Pfizer Investigational Site
Goodwood, Cape Town, 7460, South Africa
Pfizer Investigational Site
Paarl, Cape Town, 7646, South Africa
Pfizer Investigational Site
Kempton Park, Johannesburg, 1619, South Africa
Pfizer Investigational Site
Rosebank, Johannesburg, 2196, South Africa
Pfizer Investigational Site
Hatfield, Pretoria, 0083, South Africa
Pfizer Investigational Site
Bellville, 7530, South Africa
Pfizer Investigational Site
Bloemfontein, 9301, South Africa
Pfizer Investigational Site
Bloemfontein, 9330, South Africa
Pfizer Investigational Site
East London, 5201, South Africa
Pfizer Investigational Site
George, 6529, South Africa
Pfizer Investigational Site
Hurlingham, Johannesburg, 2070, South Africa
Pfizer Investigational Site
Pinetown Natal, 3610, South Africa
Pfizer Investigational Site
Polokwane, 0699, South Africa
Pfizer Investigational Site
Pretoria, 0002, South Africa
Pfizer Investigational Site
Pretoria, 0181, South Africa
Pfizer Investigational Site
Sandton, 2196, South Africa
Pfizer Investigational Site
Somerset West, 7130, South Africa
Pfizer Investigational Site
Westville, 3630, South Africa
Pfizer Investigational Site
Granollers, Barcelona, 08400, Spain
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33011, Spain
Pfizer Investigational Site
Barcelona, 08036, Spain
Pfizer Investigational Site
Barcelona, 08100, Spain
Pfizer Investigational Site
Madrid, 28006, Spain
Pfizer Investigational Site
Madrid, 28009, Spain
Pfizer Investigational Site
Madrid, 28037, Spain
Pfizer Investigational Site
Madrid, 28041, Spain
Pfizer Investigational Site
Pamplona, 31014, Spain
Pfizer Investigational Site
Seville, 41700, Spain
Pfizer Investigational Site
Zaragoza, 50007, Spain
Pfizer Investigational Site
Kharkiv, 61068, Ukraine
Pfizer Investigational Site
Lviv, 79021, Ukraine
Pfizer Investigational Site
Odesa, 65006, Ukraine
Pfizer Investigational Site
Maidenhead, Berkshire, SL6 2LH, United Kingdom
Pfizer Investigational Site
Slough, Berks, SL2 1HD, United Kingdom
Pfizer Investigational Site
Falmouth, Cornwall, TR11 2LH, United Kingdom
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT, United Kingdom
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH, United Kingdom
Pfizer Investigational Site
Saltash, Cornwall, PL12 6DL, United Kingdom
Pfizer Investigational Site
St Austell, CORNWALL, PL26 7RL, United Kingdom
Pfizer Investigational Site
Downpatrick, County Down, BT30 6HY, United Kingdom
Pfizer Investigational Site
Chesterfield, Derbyshire, S40 4TF, United Kingdom
Pfizer Investigational Site
Plymouth, Devon, PL6 7TH, United Kingdom
Pfizer Investigational Site
Bexhill-on-Sea, EAST SUSSEX, TN40 1HE, United Kingdom
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom
Pfizer Investigational Site
Leigh-on-Sea, Essex, SS3 2SQ, United Kingdom
Pfizer Investigational Site
Leslie, Fife, KY6 3LQ, United Kingdom
Pfizer Investigational Site
Limekilns, Fife, KY11 3HS, United Kingdom
Pfizer Investigational Site
Cathcart, Glasgow, G44 3DH, United Kingdom
Pfizer Investigational Site
Clarckston, Glasgow, G76 7BX, United Kingdom
Pfizer Investigational Site
Rutherglen, Glasgow, G73 2PQ, United Kingdom
Pfizer Investigational Site
Bolton, Lancashire, BL1 6AF, United Kingdom
Pfizer Investigational Site
Chelsea, London, SW3 4BP, United Kingdom
Pfizer Investigational Site
Bangor, Northern Ireland, BT19 1PP, United Kingdom
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, BT38 8TP, United Kingdom
Pfizer Investigational Site
Houston, Renfrewshire, PA6 7AR, United Kingdom
Pfizer Investigational Site
Epworth, Doncaster, South Yorkshire, DN9 1EP, United Kingdom
Pfizer Investigational Site
Saint John's, Woking, Surrey, GU21 ITD, United Kingdom
Pfizer Investigational Site
Trowbridge, WILTSHIRE, BA14 8QA, United Kingdom
Pfizer Investigational Site
Inkberrow, Worcestershire, WR7 4ED, United Kingdom
Pfizer Investigational Site
Birmingham, B37 7TR, United Kingdom
Pfizer Investigational Site
Bolton, BL4 9QZ, United Kingdom
Pfizer Investigational Site
Bolton, BL6 7AN, United Kingdom
Pfizer Investigational Site
Chesterfield, S40 1LE, United Kingdom
Pfizer Investigational Site
Cookstown, BT80 8BN, United Kingdom
Pfizer Investigational Site
Coventry, CV12 OHU, United Kingdom
Pfizer Investigational Site
Coventry, CV2 1SG, United Kingdom
Pfizer Investigational Site
Coventry, CV6 4DD, United Kingdom
Pfizer Investigational Site
Coventry, CV7 8LA, United Kingdom
Pfizer Investigational Site
Dundee, DD1 5LA, United Kingdom
Pfizer Investigational Site
Earlsdon, Coventry, CV5 6EU, United Kingdom
Pfizer Investigational Site
Glasgow, G3 8YJ, United Kingdom
Pfizer Investigational Site
Glasgow, G41 3YE, United Kingdom
Pfizer Investigational Site
Glasgow, G69 7AD, United Kingdom
Pfizer Investigational Site
Leeds, LS12 ITZ, United Kingdom
Pfizer Investigational Site
London, SE13 6LH, United Kingdom
Pfizer Investigational Site
Port Glasgow, PA14 6HW, United Kingdom
Pfizer Investigational Site
Rugby, CV21 3SP, United Kingdom
Pfizer Investigational Site
Related Publications (1)
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.
PMID: 23808960DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 1, 2001
Study Completion
March 1, 2006
Last Updated
July 14, 2006
Record last verified: 2006-07