Placebo controlled, double - blind study of ME3113 in benign prostatic hyperplasia patients with lower urinary tract symptoms (Phase II)

Meiji Seika Pharma Co., Ltd.0 个研究点目标入组 450 人开始时间: 2014年10月8日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•BPH patients with LUTS for greater than 6 months.
•Total International Prostate Symptom Score (IPSS) at the baseline visit is within a specific range.

•Have taken the following treatments;
•- Alpha blocker therapy, 5-alpha reductase inhibitor therapy, Anti-androgenic hormone therapy, All other BPH therapy, Over Active Bladder (OAB) therapy.
•- Have experience of malignant tumor diseases within 5 years.
•- Prostatic specific antigen (PSA) level is more than 10.0 ng/mL at study entry.
•- History of cardiac diseases.
•- Have evidences of cardiac diseases such as development of fatigue, palpitation, dyspnoea or angina pain.
•- History of clinically significant drug sensitivity.
•- Have complication or past history of nonarteritic anterior ischemic optic neuropathy (NAION).
•- Have a complication or past history of retinal pigment degeneration.
•- Planned to receive a surgery during the study period (any treatments requiring general anesthesia, spinal anesthesia or epidural anesthesia).
•- Have taken any other study drug in clinical studies in the past 90 days.
•- Previous administration of ME3113
•- Have judged to be an inappropriate subject for this trial by the investigator or subinvestigator.

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