NCT02038868

A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia

Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 40 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.

Detailed description

This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
DRUG	ASP4901	oral
DRUG	Tamsulosin	oral
DRUG	Placebo	oral

Timeline

• Start date: 2013-07-22
• Primary completion: 2014-04-04
• Completion: 2014-04-04
• First posted: 2014-01-17
• Last updated: 2024-11-06

Locations

2 sites across 1 country: Japan