Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (Neptune II) 


Tracking Information

Start Date  ICMJEJanuary 2010
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)		Safety variables: Incidence, severity and relationship of AEs to the study drug, Vital signs, ECG parameters, Laboratory parameters, Physical examination, PVR volume, Qmax and Qmean [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01021332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 25, 2009)		Change from baseline to endpoint in data from micturition diary, I-PSS questionnaire [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJELong Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Official Title  ICMJEAn Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 gm and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Brief Summary

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Detailed Description

This is an open-label extension study following the double blind 905-CL-055 study

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Condition  ICMJE
  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia
Intervention  ICMJEDrug: tamsulosin hydrochloride/solifenacin succinate combination
oral
Other Name: EC905
Study Arms / Comparison Groups
  • 1. tamsulosin/solifenacin combi, low dose: Experimental
    Intervention: Drug: tamsulosin hydrochloride/solifenacin succinate combination
  • 2. tamsulosin/solifenacin combi, high dose: Experimental
    Intervention: Drug: tamsulosin hydrochloride/solifenacin succinate combination

Recruitment Information

Recruitment Status  ICMJENot yet recruiting
Estimated Enrollment  ICMJE800
Estimated Completion DateMay 2011
Estimated Primary Completion DateMay 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion Criteria:

  • Any significant PVR volume (>150 mL)
GenderMale
Ages45 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Medical Clinical Development Department+ 31 (0)71 54 55745contact@nl.astellas.com
Location Countries  ICMJEAustria,   Belarus,   Belgium,   France,   Germany,   Italy,   Netherlands,   Poland,   Russian Federation,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01021332
Responsible PartyDisclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers  ICMJE905-CL-057, 2008-001212-20
Study Sponsor  ICMJEAstellas Pharma Inc
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Use Central ContactAstellas Pharma Global Development
Information Provided ByAstellas Pharma Inc