JPRN-UMIN000016236已完成未知
Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder. - Efficacy and safety results from combination treatment with Imidafenacin and Mirabegron in patients with OAB (EstIMate Study).
Clinical Research Support Center Kyushu0 个研究点目标入组 30 人开始时间: 2015年1月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 50years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Start of observation period (-4wks) 1) Patients who has contraindication of imidafenacin 1. Patients with urinary retention. 2. Patients with pyloric stenosis, duodenal ileus, enterocleisis and patients with adynamic ileus. 3. Patients with deterioration of enterokinesis. 4. Patients with narrow-angle glaucoma. 5. Patients with myasthenia gravis. 6. Patients with serious cardiac disorder. 7. Patients with a history of hypersensitivity to imidafenacin. 2) Patients who has contraindication of mirabegron. 1. Patients with a history of hypersensitivity to mirabegron. 2. Patients with serious cardiac disorder. 3. Women who have pregnancy, possibility of the pregnancy. 4. Women who are nursing. 5. Patients with serious liver dysfunction (Child-Pugh score >=10). 6. Patients taking flecainide acetate or propafenone hydrochloride. 3) Patients with severe difficulty of urination. 4) Patients with history of urinary retention 5) Patients with arrhythmia. 6) Patients with hypokalemia. 7) Patients with serious kidney dysfunction. 8) Patients with bladder cancer, prostate cancer, stones in bladder, urinary tract stones, interstitial cystitis, prostatitis and symptomatic urinary tract infection. 9) Patients with genuine stress urinary incontinence. 10) Patients with polyuria. 11) Patients with severe hypertension (SBP >=180mmHg and/or DBP >=110mmHg under sitting position). 12) Patients who have administered prohibited substances or done prohibited therapy within 4 weeks before observation period. 13) Patients who have a urology or genital surgery within the 6 months before observation period. 14) Patients with unstable lower urinary tract symptoms. 15) Patients taking drugs that have possibility of QT prolongation. 16) Any other patients who are regarded as unsuitable for this study by the investigator Treatment period (at 0 week): 1)Residual urine volume is more than 50 mL 2)Patients with QT interval >450ms or risk of QT prolongation.
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