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Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

NCT01260129 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2012-03-30

No results posted yet for this study

Summary

Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.

Conditions

  • Benign Prostatic Hypertrophy

Interventions

DRUG

Silodosin

Silodosin 8 mg orally, once daily after morning meal

DRUG

Silodosin

Silodosin 4 mg orally, twice daily after morning and evening meal

Sponsors & Collaborators

Principal Investigators

  • Jae Seung Paick, ph.D · Department of Urology, Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2011-10-31

Countries

  • South Korea

Study Locations

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Entities

Companies

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 NCT01260129 on ClinicalTrials.gov