JPRN-jRCT2080224995已完成2 期
Early phase 2 study to investigate the efficacy and safety of AKP-009 in patients with benign prostatic hyperplasia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
研究概览
简要总结
After oral administration of AKP-009 at doses of 2.5, 5 and 10 mg once daily for 12 weeks to patients with prostatic hyperplasia, in the percent change from baseline in prostate volume at Week 12, the 5 mg and 10 mg groups showed greater change than the placebo group. However, there were no significant differences with the placebo group and no dose relationship was observed. There were no major issue on the safety of AKP-009.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1) Subjects who are able to understand the details of the study and obtain written consent to participate in the study at his own discretion.
- •2) Japanese men aged 50 years or older at the time of obtaining informed consent.
- •3) Subjects diagnosed with BPH.
- •4) Subjects with a prostate volume of 30 mL or more as measured by transrectal ultrasonography.
- •5) Subjects with an International Prostate Symptom Score (IPSS) of 8 points or higher.
- •6) Subjects with a quality of life (QOL) score of 2 or higher.
- •7) Subjects who have a maximum urinary flow rate (Qmax) of less than 15 mL/sec (The voided volume have to be 150ml or more).
排除标准
- •Subjects who have a post void residual urine volume of 250 mL or more as measured by transabdominal ultrasonography.
- •Subjects with a prostate-specific antigen (PSA) level higher than 10.0 ng/mL.
- •Subjects with or strongly suspected of having disease affecting lower urinary tract function other than benign prostatic hyperplasia.
- •Subjects with a history of treatment that may affect lower urinary tract function (e.g., surgery to the lower urinary tract or prostate, indwelling bladder catheterization).
- •Subjects with prostate cancer or other malignancies or those with a history of such malignancies.
研究者
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