Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

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NCT01488578

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1-800-718-1021
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1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Official Title Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
Brief Summary The 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 Description All 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).
Condition Overactive Bladder
Intervention Drug: 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/Cohorts Tolterodine 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 Status Completed
Actual Enrollment
 (submitted: December 6, 2011)		11157
Original Actual Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date March 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01488578
Other Study ID Numbers A6121186
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012