Official Title: “A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Tamsulosin Monotherapy and Tamsulosin Plus Solifenacin in Men With a Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Tamsulosin”

The purpose of this study is to explore the additional benefit of solifenacin after 12 weeks treatment, compared with tamsulosin monotherapy in men with residual OAB symptoms

Study Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: tamsulosin
  • oral
• Drug: placebo
  • oral
• Drug: solifenacin
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • tamsulosin and placebo
• Experimental: 2
  • tamsulosin and solifenacin

Primary Measures

• Achievement level of patients' individual satisfaction
  • Time Frame: At weeks 4 and 12
    Safety Issue?: No

Secondary Measures

• Changes in urgency episodes
  • Time Frame: At weeks 4 and 12
    Safety Issue?: No
• Changes in OAB symptom scores
  • Time Frame: At weeks 4 and 12
    Safety Issue?: No
• Changes in QoL score by OAB-q
  • Time Frame: At weeks 4 and 12
    Safety Issue?: No

Inclusion Criteria:

• Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
• symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
• symptoms of urinary frequency ( >8 micturitions per 24 hours)
• On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

• Previous history of acute urinary retention
• Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
• Symptomatic acute urinary tract infection (UTI) during the screening period
• Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
• A 5-alpha reductase inhibitor if started less than 3 months prior to screening
• Patients with previous urethral, prostate or bladder neck surgery

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 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 Chair Astellas Pharma Inc  

Overall Contact: Clinical Development Administration Department  clinicaltrials_info@jp.astellas.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699049

Study ID Number: SMK-1

ClinicalTrials.gov Identifier: NCT00699049

Health Authority: Korea: Food and Drug Administration