NCT00547625已完成2 期
A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to 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
- 275
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (IPSS) sum total of questions 1-7
研究概览
简要总结
Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.
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
- •6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist.
- •Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study.
- •Meet required prostate symptom score and urine flow rate.
排除标准
- •Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months.
- •Prostate removal and various other pelvic surgeries.
- •Neurological disease or condition known to affect the bladder.
- •Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis.
- •Have taken medications such as nitrates, finasteride, or dutasteride within the year.
研究组 & 干预措施
1
Placebo Comparator
Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.
干预措施: placebo (Drug)
2
Active Comparator
Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.
干预措施: tadalafil (Drug)
结局指标
主要结局
International Prostate Symptom Score (IPSS) sum total of questions 1-7
时间窗: 6 and 12 weeks
次要结局
- Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.(12 weeks)
- Measure Uroflowmetry parameters(12 weeks)
- Evaluate safety by PSA levels and postvoid residual volume (PVR)(12 weeks)
研究者
研究点 (1)
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