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Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

NCT ID: NCT00658684

Last Updated: 2010-10-13

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

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-08-31

Brief Summary

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To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fesoterodine fumarate

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Interventions

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fesoterodine fumarate

4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day.

Exclusion Criteria

* Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
* Patient has a known neurological disease influencing bladder function.
* Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Inegeku, Chibashi, Chiba, Japan

Site Status

Pfizer Investigational Site

Akashi-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Amagasaki-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Chuou-ku, Koube-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kaibara-cho, Tanba-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Nishinomiya-shi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kawasakishi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Sagamihara-shi, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Nara, Nara, Japan

Site Status

Pfizer Investigational Site

Osaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221006&StudyName=Long%20Term%20Study%20To%20Evaluate%20the%20Safety%2C%20Tolerability%20and%20Efficacy%20of%20Fesoterodine%20for%20Overactive%20Bladder.

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Other Identifiers

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A0221006

Identifier Type: -

Identifier Source: secondary_id

A0221006

Identifier Type: -

Identifier Source: org_study_id