NCT03246880已完成3 期
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •[Visit 1]
- •Male Aged of 45 or above
- •Patients must have a diagnosis of Benign Prostatic Hyperplasia
- •IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
- •Signed and dated informed consent document indicating that the patient
- •[Visit 2]
- •IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
- •15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
- •PVR(post-void residual urine volume) ≤ 250ml
排除标准
- •Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
- •Patients with prostate cancer or PSA > 10ng/ml
- •Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
- •Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
- •Patients with acute urinary retention in 3months
- •Patients with a history of drug or alcohol abuse within 6 months
- •Patients have cardiovascular disease or associated disease which is not controlled.
- •Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
- •Patients with orthostatic hypotension
- •Patients with a history micturition syncope
- •Patients with severe or malignant retinopathy
- •Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
- •Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3
- •Patient with uncontrolled diabetes(HbA1C>9%)
- •Patients have a history of malignant tumor within 5 years
- •Patients have hypersensitivity reaction on this drug.
- •Patients treated with other investigational product within 4 weeks at first time taking the investigational product
- •Not eligible to participate for the study at the discretion of investigator
研究组 & 干预措施
Tadalafil 5mg
Active Comparator
Tadalafil 5mg, po, q.d.
干预措施: Tadalafil 5mg (Drug)
Tamsulosin 0.2mg+Tadalafil 5mg
Experimental
Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
干预措施: Tamsulosin 0.2mg (Drug)
Tamsulosin 0.2mg+Tadalafil 5mg
Experimental
Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.
干预措施: Tadalafil 5mg (Drug)
Tamsulosin 0.2mg
Active Comparator
Tamsulosin 0.2mg, po, q.d.
干预措施: Tamsulosin 0.2mg (Drug)
结局指标
主要结局
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
时间窗: From baseline at week 12
次要结局
- The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)(From baseline at week 12)
- The mean change of scores on IPSS ( International Prostate Symptom Score ), ICIQ-MLUTS( International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score(From baseline at week 8)
研究者
研究点 (1)
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