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

Last updated on October 8, 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 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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Descriptive Information
Brief TitleSpecial Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
Official TitleSpecial Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
Brief SummaryThe 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.
Detailed DescriptionAll 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.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
ConditionUrinary Bladder, Overactive
InterventionDrug: 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.
Study Groups/CohortsTolterodine tartrate.
Patients 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: June 5, 2012)
374
Original Estimated Enrollment
 (submitted: November 19, 2008)
100
Actual Study Completion DateMarch 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Detrusitol® Capsule.
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 NumberNCT00795509
Other Study ID NumbersA6121187
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 DateJune 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

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Contact

[email protected]

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