EFFECTIVENESS AND SAFETY OF SILODOSIN IN THE TREATMENT OF LUTS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA: A EUROPEAN PHASE IV CLINICAL STUDY - SiRE

• Conditions: Patients with lower urinary tract symptoms (LUTS) suggestive of a bladder outlet obstruction (BOO) associated with benign prostatic hyperplasia (BPH) requiring a medical treatment.; MedDRA version: 13.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2011-000045-20-IT
• Lead Sponsor: RECORDATI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-12
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified