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A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: solifenacin succinate (Drug); tolterodine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Principal Investigator, Affiliation: Peking University First Hospital

Summary

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Clinical Details

Official title: A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean number of micturitions per 24 hours

Secondary outcome:

Change from baseline in mean volume voided per micturition

Change from baseline in mean number of incontinence episodes per 24 hours

Change from baseline in mean urgency frequency per 24 hours

Change from baseline in mean nocturia episodes per 24 hours

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients willing and able to complete the micturition diary correctly

- Patients experiencing frequency of micturition as verified in the diary

- Patients experiencing significant post void residual volume

- OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months

or more. Exclusion Criteria:

- Significant post void residual volume

- Patients with indwelling catheters or practicing intermittent self- catheterization

- Known or suspected hypersensitivity to solifenacin succinate or other

anticholinergics or lactose

Locations and Contacts

Beijing 100000, China

Chong Qing 404000, China

Hang Zhou 310000, China

Shanghai 200000, China

Additional Information

Starting date: September 2006
Last updated: April 9, 2008

Page last updated: August 23, 2015

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