CTRI/2017/08/009487已完成3 期
A randomized, multi-centric, double blind, comparative study to evaluate efficacy and safety of fixed dose combination of Alfuzosin hydrochloride extended release and Tadalafil in comparison to Alfuzosin hydrochloride extended release in patients having Benign Prostatic Hyperplasia (BPH) and Lower urinary tract symptoms (LUTS) in India.
Sun Pharma Laboratories Limited SP0 个研究点目标入组 420 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
- 420
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
- •1.Male patients, aged 45 to 75 years, diagnosed with benign prostatic hyperplasia (BPH) and LUTS. (New or old taking alpha blockers for BPH)
- •2.Patients having IPSS score greater than 8 (moderate to severe BPH) at the time of screening.
- •3.Patient or his legally accepted representative is willing to give informed consent.
排除标准
- •1.Use of any 5-alpha-reductase inhibitor, any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit
- •2.ED therapy (er. PDE5 inhibitors), OAB for at least 4 weeks prior to Randomization.
- •3.Prostate specific antigen (PSA) beyond 4 ng/mL at screening.
- •4.History of urinary retention or lower urinary tract (bladder) stone within 6 months of screening
- •5.History of urethral obstruction due to stricture, valves, sclerosis or tumor at screening.
- •6.Clinical evidence of prostate cancer or prostatitis at screening.
- •7.Clinical evidence of any other bladder or urinary tract conditions, which may affect lower urinary tract symptom at screening
- •8.Current or recent substance abuse, including alcohol.
- •9.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
- •10.History of severe cardiac conditions, including Angina requiring certain treatment with nitrates
- •11.History of symptomatic orthostatic hypotension or recurrent dizziness, vertigo, loss of consciousness or syncope.
- •12.History of significant central nervous system disease (including stroke or spinal cord injury within 6 months of screening)
- •13.Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists or anabolic steroids at initiation (at screening)
- •14.Patients having hypersensitivity or any other contraindication to any of the Investigational products including its components.
- •15.Medical history or clinical evidence of any pelvic, as judged by the urologist, might compromise protocol compliance
- •16.Glycosylated hemoglobin (HbA1c) greater than 9% at screening.
- •17.Patients judged unfit for this study (e.g. moderate to severe hepatic impairment) by investigator
研究者
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