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NCT Number: NCT00359905

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin

Drug

8 mg daily for 12 weeks

Other names: KMD3213

Tamsulosin

Drug

0.4 mg daily for 12 weeks

Other names: Omnic

Placebo

Drug

once daily for 12 weeks

Primary outcomes

  1. Change in baseline total score on the International Prostate Symptom Score

    Time frame: 12 weeks

Secondary outcomes

  1. Change in baseline obstructive subscore of the International Prostate Symptom Score;

    Time frame: 12 weeks

  2. change in baseline irritative subscore of the International Prostate Symptom Score;

    Time frame: 12 weeks

  3. change in baseline maximum urine flow rate;

    Time frame: 12 weeks

  4. safety

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

RECORDATI GROUP

Industry

Registry information

Official study title

Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Aug 3, 2006
Registry last updated
Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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