NCT02245542已完成不适用
The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)
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
- 5,775
- 主要终点
- Change from Baseline in Nocturia quality of life by means of a patient questionnaire
研究概览
简要总结
Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia
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
- •Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months
排除标准
- •Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study
研究组 & 干预措施
BPH patients
干预措施: ALNA®OCAS® (Drug)
结局指标
主要结局
Change from Baseline in Nocturia quality of life by means of a patient questionnaire
时间窗: Baseline, after 3 months
Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire
时间窗: Baseline, after 3 months
次要结局
- Change from Baseline in residual urine volume(Baseline, after 3 months)
- Number of patients with adverse events(up to 3 months)
- Assessment of tolerability by investigator on 4-point scale(after 3 months)
- Change from Baseline in Maximum urinary flow rate (Qmax)(Baseline, after 3 months)
研究者
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