Neptune II - Open-label follow up study from Neptune I

• Research type

  Research Study

• Full title

  An open-label, long term, multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg 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.

• IRAS ID

  26237

• Eudract number

  2008-001212-20

• Research summary

  Men suffering from lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) may benefit from drug treatment. Some drugs are already available, but these may not alleviate both storage and voiding symptoms. The purpose of this study is to assess the safety and tolerability of long-term treatment of the fixed dose combination of two drugs (tamsulosin and solifenacin). If the patient decides to enter the study, he will be given the tamsulosin 0.4mg OCAS and solifenacin 6mg, but will be given an opportunity to request a dose increase to the combination with solifenacin 9mg. The study will be an open-label 40-week treatment period. Only subjects who have completed the double-blind 12-week treatment from study 905-CL-055 will be eligible to continue onto this extension study. Subjects will visit the clinic at end of double blind treatment (visit 5A), and will begin treatment with the open label combination treatment with solifenacin 6mg (visit 5B), subjects will return to the clinic 4 weeks after (visit 6) and then three more at intervals of 12 weeks (visit 7, 8 and 9).

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/63

• Date of REC Opinion

  16 Sep 2009

• REC opinion

  Further Information Favourable Opinion