NCT02244333已完成不适用
ALNA® - AWB in Pre-treated Patients With BPS
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,575
- 主要终点
- Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
研究概览
简要总结
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
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
- •Suffering from BPS symptoms
- •Preceding treating with Terazosin for at least one month
- •IPSS sum score >= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin
- •Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month
排除标准
- •Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study
研究组 & 干预措施
Patients with symptomatic BPS
干预措施: ALNA® (Drug)
结局指标
主要结局
Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire
时间窗: Baseline, after 1 month
Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale
时间窗: after 1 month
Change of Quality of Life (QoL) Index by means on patient questionnaire
时间窗: Baseline, after 1 month
次要结局
- Change from Baseline in Pulse rate (bpm)(Baseline, after 1 month)
- Global assessment of efficacy by investigator on 4-point scale(after 1 month)
- Global assessment with BPS- treatment by investigator on a 4-point scale(Baseline, after 1 month)
- Change from Baseline in maximum urinary flow rate (Qmax)(Baseline, after 1 month)
- Change from Baseline in residual urinary volume(Baseline, after 1 month)
- Change in complications due to low blood pressure(Baseline, after 1 month)
- Global assessment of tolerability by investigator on 4-point scale(after 1 month)
- Change from Baseline in blood pressure(Baseline, after 1 month)
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