An 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 [EXTENSION STUDY OF 700051793].

Trial Profile

An 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 [EXTENSION STUDY OF 700051793].

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2015

At a glance

  • Drugs Solifenacin/tamsulosin (Primary)
  • Indications Benign prostatic hyperplasia; Lower urinary tract symptoms
  • Focus Adverse reactions; Registrational
  • Acronyms Neptune II
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 15 Apr 2014 Results presented at the 29th Congress of the European Association of Urology.
    • 29 Aug 2012 New source identified and integrated (German Clinical Trials Register: DRKS00004068).
    • 07 Apr 2012 Additional locations (Hungary, Czech Republic, Slovakia) added as reported by European Clinical Trials Database.
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