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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: solifenacin succinate
  • Oral
• Drug: tolterodine
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Change from baseline in mean number of micturitions per 24 hours
  • Time Frame: 8 Weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in mean volume voided per micturition
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Change from baseline in mean number of incontinence episodes per 24 hours
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Change from baseline in mean urgency frequency per 24 hours
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Change from baseline in mean nocturia episodes per 24 hours
  • Time Frame: 8 Weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Principal Investigator Peking University First Hospital  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368706

Study ID Number: 90506/CHoTD01

ClinicalTrials.gov Identifier: NCT00368706

Health Authority: China: State Food and Drug Administration