NCT01068041已完成2 期
Effects of PH3 in Diabetic Nephropathy
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
- 100
- 试验地点
- 5
- 主要终点
- Urinary Albumin/Creatinine Ratio (UACR)
研究概览
简要总结
The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy.
The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes
- •Sitting blood pressure of <=140/90 mm Hg
- •Serum creatinine <=2.0 mg/dL
- •Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day)
- •Hemoglobin A1c <=8%
- •Women of child-bearing potential must test negative in a pregnancy test and take contraception measures to prevent pregnancy and can not be breast-feeding
- •Voluntary written consent to participate in this study
排除标准
- •History of major cardiovascular or cerebrovascular events within 6 months prior to screening
- •History of cancer
- •Receiving chronic nonsteroidal anti-inflammatory therapy
- •History of diabetic ketoacidosis
- •Has clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety
- •Has participated in other investigational trials within 28 days prior to study enrollment
- •Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment.
- •Has known allergy to the study drug
研究组 & 干预措施
C
Active Comparator
500mg active ingredient
干预措施: PH3 (Drug)
B
Active Comparator
250mg active ingredient
干预措施: PH3 (Drug)
A
Placebo Comparator
Placebo
干预措施: PH3 (Drug)
D
Active Comparator
1000mg active ingredient
干预措施: PH3 (Drug)
结局指标
主要结局
Urinary Albumin/Creatinine Ratio (UACR)
时间窗: 24 weeks
Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24
次要结局
- Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c(24 weeks)
研究者
研究点 (5)
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