Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)


Tracking Information

Start Date  ICMJEDecember 2009
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)		Change from baseline to endpoint in total International Prostate Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01018511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: November 19, 2009)
  • Change from baseline to endpoint in TUS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in data from micturition diary, I-PSS questionnaire, OAB-q, EQ-5D, PGI and CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PK variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Official Title  ICMJEA Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, 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 efficacy, safety and tolerability of combination therapy of tamsulosin and solifenacin compared to monotherapy of tamsulosin in the treatment of males with LUTS associated with BPH with a substantial storage component.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: Placebo
    oral
  • Drug: tamsulosin hydrochloride monotherapy
    oral
    Other Name: YM617
  • Drug: tamsulosin hydrochloride / solifenacin succinate combinations
    oral
    Other Name: EC905
Study Arms / Comparison Groups
  • 1. placebo: Placebo Comparator
    Intervention: Drug: Placebo
  • 2. Tamsulosin monotherapy: Active Comparator
    Intervention: Drug: tamsulosin hydrochloride monotherapy
  • 3. Tamsulosin / solifenacin combi, low dose: Experimental
    Intervention: Drug: tamsulosin hydrochloride / solifenacin succinate combinations
  • 4. Tamsulosin / solifenacin combi, high dose: Experimental
    Intervention: Drug: tamsulosin hydrochloride / solifenacin succinate combinations

Recruitment Information

Estimated Enrollment  ICMJE1452
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
  • A total I-PSS of ≥13
  • A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
  • A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion Criteria:

  • Any significant Post Void Residual volume (>150 mL)
  • A prostate with estimated weight ≥75 g as assessed by transvesical or transrectal ultrasound
  • Evidence of a symptomatic urinary tract infection
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,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Russian Federation,   Slovakia,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01018511
Responsible PartyDisclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers  ICMJE905-CL-055, 2008-001211-37
Study Sponsor  ICMJEAstellas Pharma Inc
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Use Central ContactAstellas Pharma Global Development
Information Provided ByAstellas Pharma Inc