临床试验/NCT02245529

NCT02245529已完成不适用

Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Boehringer Ingelheim0 个研究点目标入组 982 人开始时间: 2005年3月最近更新: 2014年9月19日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 982
主要终点: Number of patients with adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: Male
接受健康志愿者: 否

入选标准

•Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information

排除标准

•Patients with known hypersensitivity to Tamsulosin, or any other component of the product
•Patients with a history of orthostatic hypotension or severe liver failure

研究组 & 干预措施

Patients with benign prostatic hyperplasia (BPH)

干预措施: Tamsulosin (Drug)

结局指标

主要结局

Number of patients with adverse events

时间窗: up to 6 months

次要结局

未报告次要终点

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

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