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Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

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NCT00795509

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary 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

- Patients need to be administered Detrusitol® Capsule in order to be enrolled in the
surveillance.

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

- Patients not administered Detrusitol® Capsule.

NCT00795509
Pfizer
Completed
Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

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Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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.
All the patients 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
Urinary Bladder, Overactive
Drug: Tolterodine tartrate
Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability."
Other Name: Detrusitol® Capsule.
Tolterodine tartrate.
Patients taking Tolterodine tartrate.
Intervention: Drug: Tolterodine tartrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Detrusitol® Capsule.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00795509
A6121187
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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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