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

Late phase II study of ME3113

Meiji Seika Pharma Co., Ltd.

e-mail: clinical_trials@meiji.com

Meiji Seika Pharma Co., Ltd.

e-mail: clinical_trials@meiji.com

Interventional

Multicenter, randomized, placebo controlled, double - blind, parallel group comparison study

2

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

Have taken the following treatments during a designated period of time; 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 a cerebrovascular disorder and/or coronary artery disease or received the treatment for such disorder.
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.
Have taken any other study drug in clinical studies in the past 90 days.
Have taken the drug containing the same entity as the investigational drug of this trial in the past.
Have judged to be an inappropriate subject for this trial by the investigator or subinvestigator.

etc.

Male

Benign prostatic hyperplasia with lower urinary tract symptoms

investigational material(s)
Generic name etc : ME3113
INN of investigational material : Udenafil
Therapeutic category code : 259 Other agents for uro-genital and anal organ
Dosage and Administration for Investigational material : oral

control material(s)
Generic name etc : placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : oral

Change from baseline in total score of International Prostate Symptom Score (IPSS)

Change from baseline in the IPSS Quality of Life (QoL) Index