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Fesoterodine "add-on" Male Overactive Bladder Study

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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.

NCT00546637
Pfizer
Completed
Fesoterodine "add-on" Male Overactive Bladder Study

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Fesoterodine "add-on" Male Overactive Bladder Study
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.
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder Syndrome
  • Drug: Fesoterodine
    Fesoterodine 4mg or 8mg
  • Drug: Placebo
    Placebo
  • Experimental: Fesoterodine 4mg or 8mg
    Intervention: Drug: Fesoterodine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
947
February 2009
February 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Colombia,   Germany,   Greece,   India,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   Philippines,   Poland,   Singapore,   Slovakia,   Spain,   Sweden,   Thailand,   United States
 
 
NCT00546637
A0221009
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer,Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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