NCT00783094已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese 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
- 422
- 试验地点
- 1
- 主要终点
- Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit
- •Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
- •Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.
排除标准
- •Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit
- •History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit
- •History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit
- •Clinical evidence of prostate cancer at Visit
- •Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit
- •History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
- •History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit
- •Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
研究组 & 干预措施
Tadalafil 2.5 milligrams (mg)
Experimental
2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
干预措施: Tadalafil 2.5 mg (Drug)
Tadalafil 5 mg
Experimental
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
干预措施: Tadalafil 5 mg (Drug)
Placebo
Placebo Comparator
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
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 in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint(Baseline, 12 weeks)
- Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement(Baseline, 12 weeks)
- Number of Participants With Adverse Events During 12 Weeks of the Study(Baseline through 12 weeks)
- Change From Baseline in Blood Pressure at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Sitting Heart Rate at 12-Week Endpoint(Baseline, 12 Weeks)
- Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint(Baseline, 54 weeks)
- Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment(End of 12 weeks of double-blind through 54 weeks)
- Change From Baseline in Blood Pressure During at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in Sitting Heart Rate at 54-Week Endpoint(Baseline, 54-weeks)
- Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint(Baseline, 54 weeks)
- Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint(Baseline, 54 weeks)
研究者
研究点 (1)
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