A Multi-center, Randomized, Double-blind, Double-Dummy, Positive Parallel Controlled Study to Evaluate the Efficacy and Safety in Treatment of Mild-moderate Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 957
- 试验地点
- 40
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
研究概览
简要总结
The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of age ≥18 years;
- •Diagnosed with mild-moderate essential hypertension;
- •Participant has understood the study-required procedures, voluntarily signed informed consent.
排除标准
- •Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
- •Suffered by severe heart disease within 6 months;
- •Suffered by severe cerebrovascular disease within 6 months;
- •Suffered by severe or malignant retinopathy;
- •Out of controlled diabetes;
- •History of malignant tumor;
- •History of mental disorder;
- •Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
- •Alcohol or drug abuse;
- •Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
- •Assessed by the investigators as unsuitable for participating in the study.
研究组 & 干预措施
Stage 1 Arm A
1 SPH3127 tablet，3 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
干预措施: SPH3127 tablet (Drug)
Stage 1 Arm B
2 SPH3127 tablets，2 SPH3127 matching placebo tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
干预措施: SPH3127 tablet (Drug)
Stage 1 Arm C
4 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
干预措施: SPH3127 tablet (Drug)
Stage 1 Arm D
4 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
干预措施: Valsartan (Drug)
Stage 2 Arm A
2 SPH3127 tablets, 1 valsartan matching placebo capsule, once daily for 12 weeks.
干预措施: SPH3127 tablet (Drug)
Stage 2 Arm B
2 SPH3127 matching placebo tablets, 1 valsartan capsule, once daily for 12 weeks.
干预措施: Valsartan (Drug)
Stage 3
2 SPH3127 tablets, once daily for 40 weeks.
干预措施: SPH3127 tablet (Drug)
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12
时间窗: Measure at week 12 of treatment.
次要结局
- Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.(Measured at week 2, 4, 6, 8, 10, and 12 of treatment.)
- Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10(Measured at week 2, 4, 6, 8 and 10 of treatment.)
- Plasma concentration of SPH3127.(12 weeks.)
- Total effective rate at week 2, 4, 6, 8, 10 and 12(Measured at week 2, 4, 6, 8, 10, and 12 of treatment.)
- Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12(Measured at week 2, 4, 6, 8, 10, and 12 of treatment.)
- Number of subjects with adverse event.(12 weeks.)
- Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events(12 weeks.)