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A phase II, randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of AKP-009 administered for 24 weeks in patients with benign prostatic hyperplasia

A phase II study of AKP-009 in patients with benign prostatic hyperplasia

Irisuna Hiroki

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

aska-clinical@aska-pharma.co.jp

Irisuna Hiroki

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

+81-80-8575-1460

aska-clinical@aska-pharma.co.jp

Not Recruiting

April. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Capable of understanding the details of the study and can provide written voluntary consent to participate in the study
-Japanese male aged >=50 years at the time of informed consent
-Diagnosed with BPH
-Meet the criteria of alpha1 receptor blocker

-Prostate volume is below the standard
-IPSS is below the standard
-QOL score is below the standard
-Failure to meet criteria for urination
-PSA is above the standard
-Active urinary tract infection, bladder calculi, neurogenic bladder, diabetes mellitus with poor glycemic control, or other diseases likely to affect lower urinary tract function
-Active liver disease or icterus, or ALT or AST> 3 times the upper limit of normal (ULN), or bilirubin (total bilirubin)> 1.5 times the upper limit of normal (ULN) on laboratory tests
-Subject with severe renal impairment
-Previous treatment that affects lower urinary tract function, or requires such a treatment to be performed during the study period
-Current or previous malignancy within 5 years before informed consent
-Current, clinically significant cardiovascular disease or uncontrollable hypertension
-Current or previous disease that is considered inappropriate for participation in this study, such as severe liver disorder, jaundice, renal impairment, cardiovascular disease, endocrine disease, metabolic disorder, pulmonary disease, gastrointestinal disease, neurological disease, urological disease, immune disease, or mental disorder (especially with depression-like symptoms) and suicide attempt resulting from a mental disorder
-Current digestive system disease that is likely to affect the absorption of this study drug
-Current or previous alcohol dependency, drug dependency, or drug allergy

Male

Benign prostatic hyperplasia

Oral administration of AKP-009, placebo or dutasteride

Percent change from baseline in prostate volume at Week 24 of the dosing period

+81-43-227-1131

Mar. 26, 2025

No

none