NCT00540124已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
研究概览
简要总结
The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
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
- Double (Participant, 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
- •Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit
- •Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
- •Have not taken Finasteride therapy for at least 3 months prior to Visit
- •Have not taken Dutasteride therapy for at least 6 months prior to Visit
- •Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.
排除标准
- •Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit
- •Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit
- •History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
- •Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit
- •Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
研究组 & 干预措施
Tadalafil
Experimental
干预措施: Tadalafil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Tamsulosin
Active Comparator
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
时间窗: baseline, 12 weeks
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
次要结局
- Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score(baseline, 4 and 8 weeks)
- Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore(baseline, 4, 8, and 12 weeks)
- Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore(baseline, 4, 8, and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary(baseline, 12 weeks)
- Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore(baseline, 4, 8, and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)(baseline, 12 weeks)
- Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary(baseline, 12 weeks)
- Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary(baseline, 12 weeks)
- Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)(baseline, 12 weeks)
- Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies(12 weeks)
- Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies(12 weeks)
- Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)(baseline, 12 weeks)
研究者
研究点 (1)
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