Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence
Intervention: tolterodine extended release capsule (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To evaluate efficacy of tolterodine extended release formulation compared with immediate
release formulation in subjects with symptoms of overactive bladder
Clinical Details
Official title: A Phase Iii Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder
Secondary outcome: To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with a diagnosis of overactive bladder.
Exclusion Criteria:
- Subjects with significant stress incontinence as determined by the investigator.
- Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times
in the last year.
Locations and Contacts
Pfizer Investigational Site, Beijing 100034, China
Pfizer Investigational Site, Shanghai 200040, China
Pfizer Investigational Site, Shanghai 200127, China
Pfizer Investigational Site, Chongqing, China
Pfizer Investigational Site, Beijing 100020, China
Pfizer Investigational Site, Huangzhou, Zhejiang Province 310003, China
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2005
Last updated: October 16, 2006
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