CTRI/2009/091/000742已完成3 期
An Open Label, Randomized, Parallel Group, Prospective, Multicenter Clinical Trial for Evaluation of Efficacy and Safety of IN-ALRN-001 in Comparison with Tamsulosin in Patients with lower urinary tract symptoms associated with BPH.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- •1. Ambulatory males (≥50 years) suffering from LUTS (IPSS score 7) secondary to diagnosed BPH (Prostate volume 50 ml, by ultrasound)
- •2. Patient or his legally accepted representative is willing to provide written informed consent
排除标准
- •1. Neurogenic disorder, UTI, recent history of urinary retention, bladder stone or bladder tumor
- •2. Serum Prostate Specific Antigen (PSA) > 10 ng/ml
- •3. Uninvestigated hematuria
- •4. Serious cardiovascular diseases
- •5. Hypertension patients treated with other α1-blockers
- •6. History of postural hypotension or syncope
- •7. Hepatic insufficiency (AST/ALT ≥ 2.5 x ULN) or Renal insufficiency (serum creatinine ≥ 1.5 x ULN)
- •8. Clinically significant abnormalities on physical examination or laboratory tests
- •9. Ongoing use of prohibited medications
研究者
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