NCT00848081已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy
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
- 318
- 试验地点
- 1
- 主要终点
- Number of Men With Treatment-emergent Dizziness
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).
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
- •Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
- •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 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.
- •If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.
排除标准
- •Currently receiving alpha-blocker therapy for the treatment of hypertension.
- •History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
- •Treated with nitrates for any cardiac conditions.
- •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 prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
- •Have had a stroke or a significant injury to brain or spinal cord.
研究组 & 干预措施
Tadalafil
Experimental
干预措施: Tadalafil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Men With Treatment-emergent Dizziness
时间窗: Baseline through 12 Weeks
The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.
次要结局
- Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit(Baseline through 12 Weeks)
- International Prostate Symptom Score (IPSS) Change From Baseline(Baseline, 12 Weeks)
- Postvoid Residual Volume (PVR) Change From Baseline(Baseline, 12 Weeks)
- Uroflowmetry (Qmax) Change From Baseline(Baseline, 12 Weeks)
研究者
研究点 (1)
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