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

NCT00150449

Last updated date
Study Location
Pfizer Investigational Site
A-1040 Wien, , , Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anxiety Neuroses
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have completed the double-blind portion of the preceding trial

- Completed any protocol specified withdrawal phase and follow-up visits.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Anxiety NeurosesDetermine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders. NCT00150449
  1. A-1040 Wien,
  2. Wein,
  3. Wien,
  4. Brussels,
  5. De Pinte,
  6. Gent,
  7. Kortrijk,
  8. Lede,
  9. Liege,
  10. Sint-Denijs-Westrem,
  11. Tielt,
  12. Tournai,
  13. Tallinn,
  14. Tartu,
  15. Reims, Cedex
  16. Denguin,
  17. Elancourt,
  18. Metz,
  19. Montesson,
  20. Montigny les Metz,
  21. Saint Etienne du Gres,
  22. Wasquehal,
  23. Bad-Deurrheim,
  24. Bremerhaven,
  25. Gottingen,
  26. Gottingen,
  27. Hamburg,
  28. Kothen,
  29. Lauf,
  30. Oldenburg,
  31. Osnabrueck,
  32. Siegen,
  33. Spaichingen,
  34. Ness Ziona,
  35. Bassano del Grappa (Vicenza),
  36. Bologna,
  37. Milano,
  38. Roma,
  39. Riga,
  40. Ambacht,
  41. BV Losser,
  42. GC Nijmegen,
  43. Hoogvliet,
  44. Huizen,
  45. Losser,
  46. RC Dordrecht,
  47. Zwigndrecht,
  48. Zwijndreacht,
  49. Zwijndrecht,
  50. Zwijndrecht,
  51. Zwijndrecht,
  52. Bialystok,
  53. Bydgoszcz,
  54. Katowice,
  55. Olsztyn,
  56. Torun,
  57. Tuszyn,
  58. Warszawa,
  59. Wroclaw,
  60. Zabrze,
  61. Goodwood, Cape Town
  62. Paarl, Cape Town
  63. Kempton Park, Johannesburg
  64. Rosebank, Johannesburg
  65. Hatfield, Pretoria
  66. Bellville,
  67. Bloemfontein,
  68. Bloemfontein,
  69. East London,
  70. George,
  71. Hurlingham, Johannesburg,
  72. Pietersburg,
  73. Pinetown Natal,
  74. Pretoria,
  75. Pretoria,
  76. Sandton,
  77. Somerset West,
  78. Westville,
  79. Oviedo, Asturias
  80. Granollers, Barcelona
  81. Barcelona,
  82. Barcelona,
  83. Madrid,
  84. Madrid,
  85. Madrid,
  86. Madrid,
  87. Pamplona,
  88. Sevilla,
  89. Zaragoza,
  90. Kharkov,
  91. Lviv,
  92. Odessa,
  93. Maidenhead, Berkshire
  94. Slough, Berks
  95. Falmouth, Cornwall
  96. Fowey, Cornwall
  97. Penzance, Cornwall
  98. Saltash, Cornwall
  99. St. Austell, Cornwall
  100. Downpatrick, County Down
  101. Chesterfield, Derbyshire
  102. Plymouth, Devon
  103. Bexhill on Sea, East Sussex
  104. Bexhill-on-sea, East Sussex
  105. Leigh-On-Sea, Essex
  106. Leslie, Fife
  107. Limekilns, Fife
  108. Cathcart, Glasgow
  109. Clarckston, Glasgow
  110. Rutherglen, Glasgow
  111. Bolton, Lancashire
  112. Chelsea, London
  113. Bangor, Northern Ireland
  114. Greenisland, Carrickfergus, Northern Ireland
  115. Houston, Renfrewshire
  116. Epworth, Doncaster, South Yorkshire
  117. St. John's, Woking, Surrey
  118. Trowbridge, Wiltshire
  119. Inkberrow, Worcestershire
  120. Birmingham,
  121. Bolton,
  122. Bolton,
  123. Chesterfield,
  124. Cookstown,
  125. Coventry,
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  129. Dundee,
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  131. Glasgow,
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  133. Glasgow,
  134. Leeds,
  135. London,
  136. Port Glasgow,
  137. Rugby,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.
Official Title  ICMJE A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders
Brief Summary Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Neuroses
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
511
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Estonia,   France,   Germany,   Israel,   Italy,   Latvia,   Netherlands,   Poland,   South Africa,   Spain,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150449
Other Study ID Numbers  ICMJE 1008-100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP