Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

• Change in baseline obstructive subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• change in baseline irritative subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• change in baseline maximum urine flow rate; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

• Change in baseline obstructive subscore of the International Prostate Symptom Score;
• change in baseline irritative subscore of the International Prostate Symptom Score;
• change in baseline maximum urine flow rate;
• safety

A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved

• Drug: Silodosin
  8 mg daily for 12 weeks
  Other Name: KMD3213
• Drug: Tamsulosin
  0.4 mg daily for 12 weeks
  Other Name: Omnic
• Drug: Placebo
  once daily for 12 weeks

• Experimental: Silodosin
  Intervention: Drug: Silodosin
• Active Comparator: Tamsulosin
  Intervention: Drug: Tamsulosin
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

• Medical conditions that would confound the efficacy evaluation
• Medical conditions in which it would be unsafe to use an alpha-blocker
• Use of concomitant drugs that would confound the efficacy evaluation
• Use of concomitant drugs that would be unsafe with this alpha-blocker