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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Drug: Placebo; Drug: ASP4901; Drug: Tamsulosin

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kansai, Japan
  • Kanto, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2013
• Primary Completion (ACTUAL): April 4, 2014
• Study Completion (ACTUAL): April 4, 2014

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (ESTIMATE): January 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: BPH; ASP4901
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 4901-CL-0201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."