CTRI/2010/091/000526已完成3 期
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.0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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.
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