ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male or female >18 years old
- OAB for >3 months
- Patients with conditions that would contraindicate for fesoterodine use
- Patients with significant hepatic and renal disease or other significant unstable
diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
etc.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | UK Study Assessing Flexible Dose Fesoterodine in Adults | |||
Official Title ICMJE | A 12 Week, Multi-centre, Open Label Study To Evaluate The Efficacy, Tolerability And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder. | |||
Brief Summary | To explore the effects of fesoterodine when used in a flexible dose manner | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Bladder, Overactive | |||
Intervention ICMJE | Drug: Fesoterodine
Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated | |||
Study Arms ICMJE | Experimental: Treatment Arm
Fesoterodine 4mg, escalating to 8mg as required Intervention: Drug: Fesoterodine | |||
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 | 331 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | January 2010 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00806494 | |||
Other Study ID Numbers ICMJE | A0221058 | |||
Has Data Monitoring Committee | No | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |