Official Title: “A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-Administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)”

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Study Type: Interventional

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

Study Primary Completion Date: August 2008

A 3 arm (2 active, 1 placebo) study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in male subjects with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Intervention(s) in this Clinical Trial

• Drug: solifenacin succinate
  • oral
• Drug: tamsulosin hydrochloride
  • oral
• Drug: placebo
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • dose 1 solifenacin plus tamsulosin
• Experimental: 2
  • dose 2 solifenacin plus tamsulosin
• Placebo Comparator: 3

Primary Measures

• Evaluate the urodynamic variables
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Tolerability, safety, and efficacy of 2 doses of solifenacin succinate with tamsulosin hydrochloride
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Diagnosed with LUTS and BOO
• BOO indication by a BOOI ≥ 20
• Subject has a total IPPS score of ≥ 8 (Inclusion criteria for Baseline also)

Exclusion Criteria:

• History of urinary retention in preceding 12 months
• Current UTI or symptomatic and recurrent UTI of > 3 episodes within 12 months.
• Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
• Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
• Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 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/NCT00507455

Study ID Number: 905-CL-058

ClinicalTrials.gov Identifier: NCT00507455

Health Authority: United States: Food and Drug Administration