NCT01936870

Brief Summary

The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 7, 2017

Completed
Last Updated

June 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

September 3, 2013

Results QC Date

February 22, 2017

Last Update Submit

May 14, 2021

Conditions

Overactive Bladder (OAB)

Keywords

ToviazFesoterodinePost marketing surveillanceJapaneseOveractive BladderOABGood post marketing practiceRegulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Treatment-Related Adverse Events

    A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.

    12 Weeks

  • Clinical Efficacy Rate

    Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.

    12 Weeks

Secondary Outcomes (9)

  • Number of Participants With Treatment-Related Serious Adverse Events

    12 Weeks

  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

    12 Weeks

  • Number of Participants With Adverse Events Related to Cognitive Function Disorder

    12 Weeks

  • Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks

    Baseline, 12 Weeks

  • Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors

    12 Weeks

  • +4 more secondary outcomes

Study Arms (1)

Fesoterodine (Toviaz)

Drug: Fesoterodine (Toviaz)

Interventions

Fesoterodine (Toviaz)DRUG

Fesoterodine 4 mg or 8 mg orally. Toviaz will be dosed according to labeling. The administration and duration of therapy will be determined by the treating physician to meet the patient's needs for treatment.

Fesoterodine (Toviaz)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients prescribed fesoterodine (Toviaz) by investigators involved in protocol A0221096.

You may qualify if:

  • Patients prescribed fesoterodine (Toviaz).

You may not qualify if:

  • There are no exclustion criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

October 1, 2013

Primary Completion

May 19, 2016

Study Completion

May 19, 2016

Last Updated

June 11, 2021

Results First Posted

April 7, 2017

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.