Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)
Tracking Information
Start Date ICMJE | December 2009 |
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Estimated Primary Completion Date | August 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 ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT01018511 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 19, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms |
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Official Title ICMJE | A 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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1452 | ||||
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Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 45 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Belarus, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Russian Federation, Slovakia, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT01018511 | ||||
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Responsible Party | Disclosure Office Europe, Astellas Pharma Europe BV | ||||
Study ID Numbers ICMJE | 905-CL-055, 2008-001211-37 | ||||
Study Sponsor ICMJE | Astellas Pharma Inc | ||||
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Investigators ICMJE |
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Information Provided By | Astellas Pharma Inc |
Source: http://clinicaltrials.gov/