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

Phase 2

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: ASP4901; Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT02038868
• Lead Sponsor: Astellas Pharma Inc

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.

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 Timeline

• Study Start: 2013-07-22
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-17
• Primary Completion: 2014-04-04
• Study Completion: 2014-04-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP4901 group	ASP4901	After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).
Placebo group	Placebo	After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).
Tamsulosin group	Tamsulosin	After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).

Primary Outcome Measures

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

Secondary Outcome Measures

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