Benign prostatic hyperplasia with lower urinary tract symptoms
Conditions
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of International Prostate Symptom Score (IPSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the IPSS Quality of Life (QoL) Index | — |
Outcome results
None listed