Official Title: “A Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)”

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Study Type: Interventional

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

Study Primary Completion Date: September 2007

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Intervention(s) in this Clinical Trial

• Drug: tamsulosin hydrochloride
  • Alphablocker
• Drug: solifenacin succinate
  • antimuscarinic
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
• Active Comparator: B
• Active Comparator: C
• Active Comparator: D
• Active Comparator: E
• Active Comparator: F
• Active Comparator: G
• Active Comparator: H

Primary Measures

• Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• male patients with LUTS associated with BPH diagnosed > 3 months
• IPSS score > 13
• voiding and storage symptoms
• maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion Criteria:

• post void residual volume > 200 mL
• symptomatic urinary tract infection

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

Central Contact Study Director Astellas Pharma Europe BV  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510406

Study ID Number: 905-CL-052

ClinicalTrials.gov Identifier: NCT00510406

Health Authority: Austria: Federal Ministry for Health and Women