EVALUATION OF THE EFFICACY AND SAFETY OF SILODOSIN vs. TAMSULOSIN AND PLACEBO IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA. MULTICENTRE, RANDOMISED, DOUBLE-BLIND, CONTROLLED TRIAL WITH AN OPTIONAL LONG-TERM OPEN-LABEL EXTENSION PHASE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1400

Inclusion Criteria

1. Male subjects aged 50 years or older; 2. Presence at Visits 2 start of placebo run-in and 3 baseline , of an IPSS-1 score of 13; 3. Presence of less than 25 decrease of the IPSS-1 score between Visit 2 start of placebo run-in and Visit 3 baseline ; 4. Presence at Visits 2 start of placebo run-in and 3 baseline , of bladder outlet obstruction, as defined by a Qmax peak urine flow rate between 4 and 15 mL/sec, with a minimum voided volume of 125 mL; 5. Presence of a satisfactory compliance to study medication 80-120 at Visit 3 baseline ; 6. Able to comply with protocol procedures; 7. Able to give written informed consent 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) no
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

1.Post void bladder residual vol. of greater than 250mL; 2.Intravesical obstruct. from any cause other than BPH ; 3.Bladder calculi; 4.History of, or current, neurogenic bladder and other conditions that may affect bladder function; 5.History of any type of procedure in the past that is considered intervention for BPH or bladder neck obstruction; 6.An active urin. tract inf., or a history of recurrent urin. tract inf.; 7.Current prostatitis or a diagnosis of chronic prostatitis; 8.History of urinary retention, from a cause other than BPH, within the past 3 months; 9.History of prior prostate cancer, or prostate cancer as suspected by TRUS, DRE or clinical acumen. Subjects with a PSA greater than 10.0 ng/ml will be excluded. Subjects with a PSA between 4.0 and 10.0 should have prostate cancer ruled out to the satisfaction of the clinical Investigator with appropriate documentation of the physician s assessment; 10.History of prior invasive bladder cancer; 11.Prior radiation to the pelvis regardless of the reason or dosage of radiation; 12.Bladder catheterization or bladder or prostate instrumentation within the past 30 days; 13.History of, or current significant postural hypotension, and/or have experienced significant postural hypotension upon initiating therapy with an alfa-blocker.; 14.Clinical significant cardiovascular and cerebrovascular disease in the last 6mo; 15.Poorly controlled diabetes HbA1c 8 ; 16.Renal insuff. serum creatinine 2.0 mg/dL ; 17.Liver insuff. any LFT 2xULN ;18.Hematuria which has not been appropriately evaluated to determine safe subject participation;19.Rec. episodes of dizziness, vertigo, or loss of consciousness; 20.Pelvic surgery for malignancy or bowel resection; 21.History or current evidence of drug or alcohol abuse within the last 12 months; 22.History of allergy to alfa-blockers, or to any of the inactive agents used in this formulation; 23.Uncontrolled hypo- or hyperthyroidism; 24.Participation in a study involving the admin. of an inv. compound within the past 30days, or within 5times the half life of the prior inv. drug, whichever is longer; 25.Any subject, in the investigator s opinion, not considered suitable for enrolment; 26.History of inadequate clin. resp. to the use of alfa-blockers spec. for the release of BPH symptoms; 27.Receiving med. after V1,which preclude safe part. in the study or that may produce a confounding effect on the var.under study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Phase 1

Recordati S.p.A

Updated 11/25/2019