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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02038868

Collaborator

(none)

320

Enrollment

Locations

Arms

8.4

Actual Duration (Months)

160

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostate Hyperplasia	Drug: ASP4901 Drug: Tamsulosin Drug: Placebo	Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 22, 2013

Actual Primary Completion Date :

Apr 4, 2014

Actual Study Completion Date :

Apr 4, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP4901 group After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).	Drug: ASP4901 oral
Placebo Comparator: Placebo group After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).	Drug: Placebo oral
Active Comparator: Tamsulosin group After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).	Drug: Tamsulosin oral Other Names: YM617 Harnal

Arm

Intervention/Treatment

Experimental: ASP4901 group

After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).

Drug: ASP4901

oral

Placebo Comparator: Placebo group

After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).

Drug: Placebo

oral

Active Comparator: Tamsulosin group

After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).

Drug: Tamsulosin

oral

Other Names:

YM617

Harnal

Outcome Measures

Primary Outcome Measures

Change from baseline in total IPSS (International Prostate Symptom Score) [baseline and at the final evaluation (up to 5 weeks)]

Secondary Outcome Measures

Change from baseline in each symptom score of IPSS [baseline and at the final evaluation (up to 5 weeks)]
Change from baseline in IPSS QOL (quality of life) score [baseline and at the final evaluation (up to 5 weeks)]
Proportion of IPSS responder [baseline and at the final evaluation (up to 5 weeks)]
"IPSS responder" is defined as 25% improvement in IPSS
Plasma concentration of ASP4901 [up to 5 weeks]
only for ASP4901 group
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [up to 5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 74 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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