JPRN-jRCT2080221911未知2 期
Placebo controlled, double - blind, dose finding study of ME3113 in benign prostatic hyperplasia patients with lower urinary tract symptoms (Phase II)
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against grass pollen allergyGrass pollen allergyMedDRA version: 18.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870EUCTR2014-005471-88-ESINMUNOTEK, S.L.180
进行中（未招募）
不适用
Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extractMites allergyMedDRA version: 18.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870EUCTR2015-000820-27-ESInmunotek, S.L.180
进行中（未招募）
不适用
Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.EUCTR2005-005975-13-EEPIERRE FABRE MEDICAMENT600
进行中（未招募）
1 期
Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.Seasonnal Allergic rhinitis Prospective, multicentric, international, randomised, double-blind trial in six parallel groups: 4 doses of the test product, active control and placebo. This study is intended to evaluate the efficacy and a dose response of V0114 (l-MEQUITAZINE) in a clinical situation with patients having a hay fever.EUCTR2005-005975-13-FRPIERRE FABRE MEDICAMENT600
进行中（未招募）
1 期
Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.Prospective, multicentric, international, randomised, double-blind trial in six parallel groups: 4 doses of the test product, active control and placebo. This study is intended to evaluate the efficacy and a dose response of V0114 (l-MEQUITAZINE) in a clinical situation with patients having a hay fever.EUCTR2005-005975-13-CZPIERRE FABRE MEDICAMENT600