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

NCT00359905 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1228

Last updated 2009-02-19

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Silodosin

8 mg daily for 12 weeks

DRUG

Tamsulosin

0.4 mg daily for 12 weeks

DRUG

Placebo

once daily for 12 weeks

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Christopher Re Chapple, BSc MD · Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-05-31
Completion
2008-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00359905 on ClinicalTrials.gov