EUCTR2011-000045-20-IT进行中（未招募）不适用
EFFECTIVENESS AND SAFETY OF SILODOSIN IN THE TREATMENT OF LUTS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA: A EUROPEAN PHASE IV CLINICAL STUDY - SiRE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- RECORDATI
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients with lower urinary tract symptoms (LUTS) suggestive of a bladder outlet obstruction (BOO) associated with benign prostatic hyperplasia (BPH) requiring a medical treatment. Inclusion Criteria: - Clinical diagnosis of BPH by the urologist; - Male subjects aged 60 years or older; - IPSS total score ?12 at Visit 1 (Screening) and 2 (Baseline); - Able to comply with protocol procedures; - Written informed consent obtained before beginning any investigational procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria: Subjects will be excluded from participation if they meet any of the following criteria: - Hypersensitivity to the active substance or to any of the excipients; - Patients for whom cataract surgery is scheduled; - History of orthostatic hypotension or syncope; - Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula); - Severe hepatic impairment; - Concomitant use of other a-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serulata/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline); - Concomitant use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible PK interaction); - Prostate cancer; - History of prostate or bladder neck surgery, including TURP, TUNA, laser or other minimally invasive therapy; - Active urinary tract infection; - Acute or recurrent prostatitis (more than 3 times in the last year); - History of neurological disease that may affect bladder function; - Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, PTCA, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months); - History or current evidence of drug or alcohol abuse within the last 12 months; - Participation in a study involving the administration of an investigational compound within the past 30 days; - Any other condition which, in the investigator`s judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
研究者
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