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

Anxiety Neuroses Clinical Trial

Official title:

A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150449
• Other study ID #: 1008-100
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: July 13, 2006
• Start date: January 2001
• Est. completion date: March 2006

Study information

• Verified date: July 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Neuroses

Intervention

Drug:
• Pregabalin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Estonia,  France,  Germany,  Israel,  Italy,  Latvia,  Netherlands,  Poland,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Tolerability

External Links

•   To obtain contact information for a study center near you, click here.