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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Benign Prostate Hyperplasia

Intervention / Treatment
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* Drug: ASP4901
* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP4901 group<br>After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period). | Drug: ASP4901<br>* oral<br>|
| Placebo Comparator: Placebo group<br>After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period). | Drug: Placebo<br>* oral<br>|
| Active Comparator: Tamsulosin group<br>After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period). | Drug: Tamsulosin<br>* oral<br>* Other names: Harnal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total IPSS (International Prostate Symptom Score) |  | baseline and at the final evaluation (up to 5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | IPSS responder is defined as 25% improvement in IPSS | baseline and at the final evaluation (up to 5 weeks) | 
| Plasma concentration of ASP4901 | only for ASP4901 group | up to 5 weeks | 
| Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs |  | up to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP4901, BPH