Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

Phase 3

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT00139724
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Shanghai, China