KCT0002940招募中未知
A multicenter, randomized, duoble-blind clinical trial to evaluate the efficacy and safety of GUGUTAMS capsule in patients with benign prostatic hyperplasia
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 404
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •1.Males, 50 years or older
- •2.diagnosed with BPH
- •3.Subjects who provide signed informed consent at the start of the study
- •1.Subjects with the Total International Prostate Symptom Score (IPSS) greater than or equal to 13
- •2. Subjects who have peak flow rate (Qmax) = 4 mL/sec and = 15 mL/sec, minimum voided volume = 150mL
- •3. Subjects who have postvoid residual volume (PVR) < 150 m
排除标准
- •1. Subjects who show hypersensitivity to the investigational products and the components.
- •2. Subjects who have sulfonamide allergy
- •3. Subjects whose Prostate-Specific Antigen (PSA) values are greater than 4ng/mL (subjects with a PSA = 4ng/mL are required to have a prostate biopsy negative for malignance)
- •4.Subjects with the clinical evidence of urinary tract infection/ inflammation or other urology diseases except BPH
- •5. Subjects with clinical evidence of genito-urinary malignant tumors including prostate or bladder cancer.
- •6. Subjects who have history of prostate surgery or who are scheduled prostate surgery.
- •7. Subjects who had cystoscopy or catheter procedure
- •8. Subjects who had AUR within 3 months
- •9. Subjects with orthostatic hypotension
- •10. Subjects who have history of orthostatic hypotension with taking a-blocker for the first time.
- •11. Subjects with uncontrollable diabetes (HbA1c exceeding 9%)
- •12. Subjects who have taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) at Visit 1
- •13. Subjects who have taken Finasteride, Dutasteride and hormone therapy for before Visit 1
- •14. Subjects with severe hepatic impairment (Child-Pugh Class C)
- •15. Subjects with clinical evidence of severe renal impairment (Scr > 2 mg/dl)
- •16. Subjects who experienced myocardial infarction within the last 90 days
- •17. Subjects who experienced New York Heart Association Class 2 or greater heart failure in the last 6 months
- •18. Subjects who have unstable angina or had angina during intercourse
- •19. Subjects with hypotension (sitSBP<90 mmHg or sitDBP<50mmHg), or uncontrolled hypertension (sitSBP >170 mmHg or sitDBP >100 mmHg)
- •20. Subjects with hereditary retinal degenerative diseases including retinitis pigmentosa
- •21. Subjects with vision loss of one eye due to Non-arteritic anterior ischemic optic neuropathy, (NAION)
- •22. Subjects with certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord
- •23. Subjects with galactose intolerance,Lapp lactase deficiency, glucose-galactose malabsorption
- •24. Subjects with history or current evidence of alcohol or drug abuse
- •25. Subjects who have no intention of using a proper contraceptive method
- •26. Subjects who have participated in other clinical studies to have been dosed other investigational products or other treatment.
- •27. Subjects who are judged to be inappropriate to enroll in study from discretion of the investigator
研究者
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