Fesoterodine "add-on" Male Overactive Bladder Study

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NCT00546637

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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

- Men aged 40 years and above.

- On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).

- Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

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


- Contraindication to fesoterodine (antimuscarinics).


- Previous history of acute urinary retention requiring catheterization or severe
voiding difficulties in the judgment of the investigator, prior to baseline.


- Unable to follow the study procedures, including completion of self-administered
bladder diary and patient reported outcome questionnaires.

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Overactive Bladder SyndromeFesoterodine "add-on" Male Overactive Bladder Study
NCT00546637
  1. Birmingham, Alabama
  2. Gilbert, Arizona
  3. Gilbert, Arizona
  4. Litchfield Park, Arizona
  5. Mesa, Arizona
  6. Phoenix, Arizona
  7. Tucson, Arizona
  8. La Mesa, California
  9. Newport Beach, California
  10. San Bernardino, California
  11. San Diego, California
  12. San Diego, California
  13. Aurora, Colorado
  14. Denver, Colorado
  15. Jupiter, Florida
  16. Orange City, Florida
  17. West Palm Beach, Florida
  18. Dunwoody, Georgia
  19. Evansville, Indiana
  20. Jeffersonville, Indiana
  21. Newburgh, Indiana
  22. Des Moines, Iowa
  23. Iowa City, Iowa
  24. Baltimore, Maryland
  25. Owings Mills, Maryland
  26. Watertown, Massachusetts
  27. Flint, Michigan
  28. St. Clair Shores, Michigan
  29. Troy, Michigan
  30. Utica, Michigan
  31. West Bloomfield, Michigan
  32. West Bloomfield, Michigan
  33. Minneapolis, Minnesota
  34. Omaha, Nebraska
  35. Sewell, New Jersey
  36. Albany, New York
  37. Garden City, New York
  38. Kingston, New York
  39. New York, New York
  40. Poughkeepsie, New York
  41. Syracuse, New York
  42. Williamsville, New York
  43. Durham, North Carolina
  44. Greensboro, North Carolina
  45. Fargo, North Dakota
  46. Fargo, North Dakota
  47. Cincinnati, Ohio
  48. Columbus, Ohio
  49. Columbus, Ohio
  50. Bethany, Oklahoma
  51. Portland, Oregon
  52. Bala Cynwyd, Pennsylvania
  53. Camp Hill, Pennsylvania
  54. Pittsburgh, Pennsylvania
  55. Charleston, South Carolina
  56. Greer, South Carolina
  57. Austin, Texas
  58. Austin, Texas
  59. Houston, Texas
  60. Tacoma, Washington
  61. Madison, Wisconsin
  62. Milwaukee, Wisconsin
  63. Antwerpen,
  64. Edegem,
  65. Leuven,
  66. Salvador, BA
  67. Curitiba, PR
  68. Rio de Janeiro, RJ
  69. Porto Alegre, RS
  70. São Paulo, SP
  71. Campos do Jordão, São Paulo
  72. Victoria, British Columbia
  73. Winnipeg, Manitoba
  74. Barrie, Ontario
  75. North Bay, Ontario
  76. Toronto, Ontario
  77. Toronto, Ontario
  78. Chicoutimi, Quebec
  79. Pointe-Claire, Quebec
  80. Sherbrooke, Quebec
  81. Medellin, Antioquia
  82. Bogota, Cundinamarca
  83. Berlin,
  84. Frankfurt,
  85. Goettingen,
  86. Hagenow,
  87. Lauenburg,
  88. Leipzig,
  89. Oberursel,
  90. Wiesbaden,
  91. Ioannina, Ipiros
  92. Patras,
  93. Thessaloniki,
  94. Ludhiana, Punjab
  95. Lucknow, Uttar Pradesh
  96. Lucknow, Uttar Pradesh
  97. New Delhi,
  98. Bucheon-si, Gyunggi-do
  99. Pusan,
  100. Seoul,
  101. Seoul,
  102. Kuching, Sarawak
  103. Kuching, Sarawak
  104. Roermond,
  105. Tilburg,
  106. Zutphen,
  107. Bodø,
  108. Oslo,
  109. Cebu City, Cebu
  110. Bacolod City,
  111. Makati City,
  112. Manila,
  113. Manila,
  114. Quezon City,
  115. Bialystok,
  116. Gdansk,
  117. Gdansk,
  118. Lodz,
  119. Myslowice,
  120. Wroclaw,
  121. Singapore,
  122. Singapore,
  123. Banska Bystrica,
  124. Bratislava,
  125. Martin,
  126. Piestany,
  127. Skalica,
  128. Martorell, Barcelona
  129. Getafe, Madrid
  130. Manacor, Palma de Mallorca
  131. Boras,
  132. Jonkoping,
  133. Skovde,
  134. Stockholm,
  135. Stockholm,
  136. Ratchathewi, Bangkok
  137. Amphoe Mueang, Chiang Mai
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Overactive Bladder SyndromeLong-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
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  1. Monheim,
ALL GENDERS
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Overactive Bladder SyndromeA Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
NCT00220363
  1. Monheim,
ALL GENDERS
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MULTIPLE SITES
Overactive Bladder SyndromeLong-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
NCT00220376
  1. RTP, North Carolina
ALL GENDERS
18 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fesoterodine "add-on" Male Overactive Bladder Study
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.
Brief Summary To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder Syndrome
Intervention  ICMJE
  • Drug: Fesoterodine
    Fesoterodine 4mg or 8mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Fesoterodine 4mg or 8mg
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: October 22, 2010)		947
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2007)		900
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged 40 years and above.
  • On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
  • Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

  • Contraindication to fesoterodine (antimuscarinics).
  • Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
  • Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 40 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 Belgium,   Brazil,   Canada,   Colombia,   Germany,   Greece,   India,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   Philippines,   Poland,   Singapore,   Slovakia,   Spain,   Sweden,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00546637
Other Study ID Numbers  ICMJE A0221009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer,Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2011

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