Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Immunotherapy of atherosclerosis
研究概览
简要总结
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity
详细描述
The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baseline waist diameter over 90 and 80 cm for men and women, respectively
排除标准
- •Pregnant and lactating women
- •Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
研究组 & 干预措施
V6 recipients
Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month
干预措施: atherosclerosis vaccine (Biological)
Placebo recipients
Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month
干预措施: Placebo pills (Biological)
结局指标
主要结局
Immunotherapy of atherosclerosis
时间窗: 1 month
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
次要结局
- Effect on hypertension(1 month)
- Effect on glucose levels(1 month)
- Effect on anthropomorphic indices of obesity(1 month)