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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359905

Enrollment

1228

Registered

2006-08-03

Start date

2006-05-31

Completion date

2008-01-31

Last updated

2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, alpha-blockers

Brief summary

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.

Detailed description

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

Interventions

DRUGSilodosin

8 mg daily for 12 weeks

DRUGTamsulosin

0.4 mg daily for 12 weeks

DRUGPlacebo

once daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in baseline total score on the International Prostate Symptom Score	12 weeks

Secondary

Measure	Time frame
Change in baseline obstructive subscore of the International Prostate Symptom Score;	12 weeks
change in baseline irritative subscore of the International Prostate Symptom Score;	12 weeks
change in baseline maximum urine flow rate;	12 weeks
safety	52 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026