This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

NCT ID: NCT00943735

Last Updated: 2018-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

774 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.

Detailed Description

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This is a non-interventional, observational study. Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Fesoterodine arm

subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy

Fesoterodine

Intervention Type DRUG

Fesoterodine 4 mg and 8 mg QD

Your Way

Intervention Type BEHAVIORAL

early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB

Interventions

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Fesoterodine

Fesoterodine 4 mg and 8 mg QD

Intervention Type DRUG

Your Way

early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients \>=18 years old
* Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.

Exclusion Criteria

* Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)
* Have participated in any other studies involving study drugs within 30 days prior to entry in the study
* Subjects who have previously taken fesoterodine.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221078

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0221078

Identifier Type: -

Identifier Source: org_study_id

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