NCT05370625招募中不适用
A Multicentric, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Valbiotis
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure at V4
研究概览
简要总结
The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension following 12 weeks of daily intake.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure < 100 mmHg
- •Body Mass Index (BMI) between 18.5 and 35 kg/m²
- •Weight stable within ± 5 % in the last three months
- •No significant change in food habits or in physical activity in the 3 months prior to randomization and agreeing to keep them unchanged throughout the study
排除标准
- •Known or suspected secondary hypertension
- •Known hypertensive retinopathy and/or hypertensive encephalopathy;
- •History of spontaneous or drug-induced angioedema;
- •Clinically significant valvular heart disease or severe aortic stenosis
- •History of acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to screening
- •Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator
结局指标
主要结局
Systolic Blood Pressure at V4
时间窗: V4 (12 weeks of intervention)
Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
次要结局
- Evolution of the fasting blood concentration of triglycerides(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of Systolic Blood Pressure(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of the fasting blood concentration of total cholesterol(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of the fasting blood concentration of LDL cholesterol(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of fasting blood concentration of hsCRP(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of hip circumference(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of cardiovascular disease risk(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of Diastolic Blood Pressure(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of fasting blood glycemia(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of the fasting blood concentration of non-HDL cholesterol(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of waist circumference(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of waist hip Ratio(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of the fasting blood concentration of HDL cholesterol(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Evolution of body weight(V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
- Delay of occurence of pharmacological treatment requirement for hypertension from V1(V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks))
研究者
研究点 (2)
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