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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-01-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Silodosin

Group Type EXPERIMENTAL

Silodosin

Intervention Type DRUG

8 mg daily for 12 weeks

Tamsulosin

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

0.4 mg daily for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily for 12 weeks

Interventions

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Silodosin

8 mg daily for 12 weeks

Intervention Type DRUG

Tamsulosin

0.4 mg daily for 12 weeks

Intervention Type DRUG

Placebo

once daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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KMD3213 Omnic

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No