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

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 300 人开始时间: 待定最近更新: 2025年4月28日

适应症

试验速览

暂无简介。

•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

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

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发起方