NCT01488578

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,157 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Tolterodine tartrate	Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-12-08
• Last updated: 2021-01-28
• Results posted: 2012-06-14