Official Title: “An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US”

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2005

Intervention(s) in this Clinical Trial

• Drug: solifenacin succinate
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.
  • Time Frame: Weeks 1, 4, 8 and 12
    Safety Issue?: No

Secondary Measures

• To assess the improvement in urge incontinence, frequency,nocturia, and urgency
  • Time Frame: Weeks 1, 4, 8 and 12
    Safety Issue?: No
• Number of patients satisfied with treatment
  • Time Frame: Weeks 1, 4, 8 and 12
    Safety Issue?: No
• Assessment of efficacy
  • Time Frame: End of study
    Safety Issue?: No
• Evaluation of the safety and tolerability
  • Time Frame: Baseline to end of study
    Safety Issue?: No

Inclusion Criteria:

• Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
• Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
• At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
• Prior to treatment with tolterodine tartrate extended release, patients must have had
• OAB syndrome for 3 or more months.

Exclusion Criteria:

• Previous treatment with darifenacin
• Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
• Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
• Clinically significant outflow obstruction as determined by the Investigator
• Uncontrolled narrow angle glaucoma, urinary or gastric retention.
• All patients with severe renal or hepatic impairment will be excluded
• Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Astellas Pharma US, Inc.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00454740

Study ID Number: 905-UC-006

ClinicalTrials.gov Identifier: NCT00454740

Health Authority: United States: Food and Drug Administration

Link to results on ClinicalStudyResults.org