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

Phase 2CompletedNCT02038868

Astellas Pharma Inc320 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

320

Conditions

Benign Prostate Hyperplasia

Interventions

ASP4901DRUG

oral

TamsulosinDRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: MALEMin age: 40 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * dysuria associated with BPH for at least 12 weeks before providing consent * a total IPSS core of 13 or higher * a QOL score of 3 or higher * a maximum urinary flow rate (Qmax) of ≥4 mL/sec and \<15 mL/sec. * a prostate volume of ≥20 mL. Exclusion Criteria: * A postvoid residual volume (PVR) of \>350 mL * A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study * A cataract operation scheduled to be performed during the study period * Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study * Hypersensitivity to ASP4901 or tamsulosin hydrochloride * Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant

Locations (2)

Unnamed facility

Kansai, Japan

Unnamed facility

Kanto, Japan

Outcomes

Primary Outcomes

Change from baseline in total IPSS (International Prostate Symptom Score)

Time frame: baseline and at the final evaluation (up to 5 weeks)

Secondary Outcomes

Change from baseline in each symptom score of IPSS

Time frame: baseline and at the final evaluation (up to 5 weeks)

Change from baseline in IPSS QOL (quality of life) score

Time frame: baseline and at the final evaluation (up to 5 weeks)

Proportion of IPSS responder

"IPSS responder" is defined as 25% improvement in IPSS

Time frame: baseline and at the final evaluation (up to 5 weeks)

Plasma concentration of ASP4901

only for ASP4901 group

Time frame: up to 5 weeks

Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs

Time frame: up to 5 weeks

Data from ClinicalTrials.gov

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