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Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Last updated on November 12, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects intend to treat their overactive bladder who are prescribed
Detrusitol Capsule by their physicians.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who have been prescribed Detrusitol Capsule before.

NCT01488578
Pfizer
Completed
Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

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Descriptive Information
Brief TitleTolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Official TitlePostmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
Brief SummaryThe objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Detailed DescriptionAll the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).
ConditionOveractive Bladder
InterventionDrug: Tolterodine tartrate
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.
Other Name: Detrusitol Capsule,Tolterodine tartrate.
Study Groups/CohortsTolterodine tartrate.
Subjects taking Tolterodine tartrate.
Intervention: Drug: Tolterodine tartrate
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: December 6, 2011)
11157
Original Actual EnrollmentSame as current
Actual Study Completion DateMarch 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Exclusion Criteria:

  • Subjects who have been prescribed Detrusitol Capsule before.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01488578
Other Study ID NumbersA6121186
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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