Status:

COMPLETED

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

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Urinary Bladder, Overactive

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

246 Patients enrolled

Trial Details

Trial ID

NCT00368706

Start Date

September 1 2006

End Date

March 1 2008

Last Update

April 10 2008

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Beijing, China, 100000

2

Chongqing, China, 404000

3

Hangzhou, China, 310000

4

Shanghai, China, 200000