NCT01139762已完成3 期
A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
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
- 696
- 试验地点
- 1
- 主要终点
- Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
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
- •Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
- •All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- •Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
- •Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- •Finasteride or dutasteride use at any time.
- •Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
- •Have prostate enlargement measured by ultrasound at screening.
排除标准
- •Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].
- •Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- •Have problems with kidneys, liver, or nervous system
- •Have uncontrolled diabetes
- •Have had a stroke or a significant injury to brain or spinal cord.
- •Have scheduled or planned surgery during the course of the study.
研究组 & 干预措施
Tadalafil
Experimental
干预措施: Tadalafil (Drug)
Tadalafil
Experimental
干预措施: Finasteride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Finasteride (Drug)
结局指标
主要结局
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
时间窗: Baseline, 12 weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
次要结局
- Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks(Baseline, 4 weeks, 26 weeks)
- Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
- Patient Global Impression of Improvement (PGI-I) at 26 Weeks(26 weeks)
- Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks(26 weeks)
- Clinician Global Impression of Improvement (CGI-I) at 26 Weeks(26 weeks)
- Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks(Baseline, 26 weeks)
- Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks(Baseline, 4 weeks, 12 weeks, 26 weeks)
研究者
研究点 (1)
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