CTRI/2014/03/004463暂停4 期
A prospective, open-label, multi-center, post-marketing study to evaluate the efficacy and safety of Silodal (silodosin) in Indian male patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
Ranbaxy Laboratories Ltd0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Outpatients aged 45 or over
- •2.Patients with a total I-PSS score of 13 or higher
- •3.Patients with a prostate volume measured by transabdominal ultrasonography or TRUS of >= 20 ml.
- •4.Patients with a maximum urinary flow rate (Qmax) of 4-15ml/sec (with voided urine volume >=125 ml).
排除标准
- •1.Patients with a residual urinary volume of >=250ml
- •2.Patients with a history of prostatectomy
- •3.Patients with PSA level > 4.0ng/mL
- •4.Patients with a history of intrapelvic radiation therapy
- •5.Patients with prostate cancer or suspected prostate cancer
- •6.Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection.
- •7.Patients conducting self-catheterization
- •8.Patients with renal impairment
- •9.Patients with hepatic impairment.
- •10.Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- •11.Patients with a history of an allergy to α-blockers
- •12.Patients with orthostatic hypotension at around screening visit
- •13.Patients with an experience of other investigational product treatments within 4 weeks form screening visit.
- •14.Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study
- •15.Patients who have taken alpha blockers within the 2 weeks from the start of the therapy
- •16.Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study.
- •17.Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator.
- •18.Any contra-indication to silodosin as mentioned in the prescribing information.
研究者
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