Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of 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
- •Participants aged 18 years or more;
- •Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification;
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •BP ≥ 180/110 mmHg;
- •Participants with BMI (body mass index) ≥ 40 Kg/m2;
- •Previous diagnosis of secondary hypertension;
- •History of Target Organ Injury;
- •History of cardiovascular, hepatic and renal disease;
- •History of gout, Diabetes Mellitus and hypokalemia;
- •Current medical history of cancer;
- •Current smoking;
- •History of alcohol abuse or drug use;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Known allergy or hypersensitivity to the medicines components used during the clinical trial;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
LENINGRADO 5
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.
干预措施: LENINGRADO 5 association (Drug)
LENINGRADO 5
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Leningrado 5 association and 1 tablet Natrilix® SR placebo.
干预措施: Natrilix SR Placebo (Other)
Natrilix® SR
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo.
干预措施: Natrilix® SR (Drug)
Natrilix® SR
The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Natrilix® SR 1,5 mg and 1 tablet Leningrado 5 association placebo.
干预措施: Leningrado 5 association Placebo (Other)
结局指标
主要结局
Change in systolic blood pressure levels, as measured by ABPM at the initial visit and final visit.
时间窗: 70 days
次要结局
- Incidence and severity of adverse events recorded during the study(101 days)