A Randomized, Open Label, Active-Controlled, and Multi-Center Phase III Clinical Trial to compare the safety and efficacy of Silodosin with that of Tamsulosin in patients of Benign Prostatic Hyperplasia

M/s. MSN Laboratories Ltd.4 个研究点分布在 1 个国家目标入组 200 人开始时间: 待定

适应症

试验速览

阶段: 3 期
发起方
入组人数: 200
试验地点: 4
主要终点: Primary Change in baseline score on the American Urological Association Symptom Index [Time Frame: 12 weeks ] The primary safety variable for this clinical trial is to compare the safety and tolerability of Silodosin with the placebo. The number of adverse events in each arm will be documented to evaluate the safety profile of silodosin.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, open label, parallel group, multi cantre trial comparing the safety and efficacy of Silodosin with that of Tamsulosin in patients of Benign Prostatic Hyperplasia in 200 patients that will be conducted in four centres in India.

研究设计

分配方式: Computer generated randomization
盲法: Open Label

入排标准

入选标准

•■All patients with duly filled and signed in ICFs [Informed Consent Forms] ■Ages: > 45 years and < 80 years ■Genders Eligible for Study: males only ■Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.
•■A mean symptoms score of at least 8 [Symptoms of BPH will be assessed as per American Urological Association Symptom Index, which assesses the occurrence of seven symptoms characteristic of benign prostatic hyperplasia during the preceding week, each scored on a scale from 0 (absent) to 5 (severe)].
•■Mean peak urinary-flow rate of no more than 15 ml per second and no less than 4 ml per second, with a minimal voided volume of 125 ml, and a mean residual volume after voiding of less than 300 ml.■Prostate-specific antigen [PSA] values of > 4 iu/mL■Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 mL/min by Cockroft and Gault formula.

排除标准

•■Patients unwilling to sign on ICF■Patients, who have taken an -adrenergic?agonist drug, a cholinergic agonist or antagonist drug, a topical -adrenergic?antagonist drug for glaucoma, or any antihypertensive drug except a diuretic or an angiotensin-converting?enzyme inhibitor within two weeks before the lead-in period ■Patients, who have taken an estrogen, androgen, or drug causing androgen inhibition within the preceding three months■Patients, an episode of unstable angina pectoris, a myocardial infarction, a transient ischemic attack, or a cerebrovascular accident in the past six months■Patients with insulin-dependent diabetes mellitus■Patients with orthostatic hypertension [defined as a difference of more than 20 mm Hg between the systolic blood pressure measured when the man was standing and that measured when he was supine, independent of concomitant changes in pulse or symptoms of postural hypotension]■Patients with history of syncope; a blood pressure of less than 90/70 mm Hg when the man was sitting■Patients with a history of carcinoma of the prostate, pelvic irradiation, or urethral stricture; surgery for benign prostatic hyperplasia or bladder-neck obstruction; current evidence of prostatic carcinoma; active urinary tract disease, cystoscopy, or biopsy of the prostate within the previous two weeks■Patients with prior pelvic surgery that was likely to interfere with normal bladder function■Patients with a history of recurrent urinary tract infections or an in infection of the urinary tract, including asymptomatic bacteriuria, within the preceding two months■Patients with clinically important renal or hepatic impairment (as evidenced by a serum creatinine concentration greater than 2.0 mg per deciliter [177 m/ mol per liter] or a serum alanine aminotransferase concentration more than 1.5 times the upper limit of normal); and a serum concentration of prostate-specific antigen above 10 ng per milliliter■Patients with a history of chronic hepatitis B or C infection, HIV infection, ■Patients with presence or history of malignancy (within the last 2 years), or alcohol or drug abuse.
•■Patients who have received an experimental drug within 28 days of study entry will be excluded from participation, as will be patients with a history of sensitivity to silodosin, Tamsulosin or their excipients.

结局指标

主要结局

Primary Change in baseline score on the American Urological Association Symptom Index [Time Frame: 12 weeks ] The primary safety variable for this clinical trial is to compare the safety and tolerability of Silodosin with the placebo. The number of adverse events in each arm will be documented to evaluate the safety profile of silodosin.

时间窗: 12 weeks

次要结局

Change in baseline urine flow rate [Time Frame: 12 weeks ] ? Change in prostate-specfic antigen [Time Frame: 12 weeks ] This includes clinical laboratory tests (hematology, biochemistry, and urinalysis), physical examinations, vital signs (body temperature, heart rate, respiratory rate, and blood pressure), and 12-lead electrocardiograms. The clinical laboratory tests (complete blood count, electrolytes, serum lipids, kidney function, pancreatic enzymes, aminotransferases, y-glutamyltransferase, and alkaline phosphatase) will be performed by a central laboratory at the time of screening and at the time of completion of the study.(12 weeks)

研究者

发起方

M/s. MSN Laboratories Ltd.

研究点 (4)

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