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Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

NCT00861757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2011-06-28

Study results available
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Summary

This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Tadalafil

by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks

DRUG

Placebo

PO, QD (30 min after meal) for 12 weeks

DRUG

Tamsulosin

PO, QD (30 min after meal) for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00861757 on ClinicalTrials.gov