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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-22

Study Completion Date

2014-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

NCT02058368

Prostatic Hyperplasia

COMPLETED PHASE3

A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)

NCT01391338

Chronic Abacterial Prostatitis Chronic Pelvic Pain Syndrome

COMPLETED PHASE2

(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia

NCT05236634

Benign Prostatic Hyperplasia

UNKNOWN NA

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

NCT01203371

Hyperplasia

WITHDRAWN PHASE3

Study to Characterise the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms

NCT02245490

Prostatic Hyperplasia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostate Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASP4901 group

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

Group Type EXPERIMENTAL

ASP4901

Intervention Type DRUG

oral

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Tamsulosin group

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASP4901

oral

Intervention Type DRUG

Tamsulosin

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

YM617 Harnal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No