NCT06704815已完成不适用
Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.
Servier Affaires Médicales1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 arms
研究概览
简要总结
The primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating Viacoram® plus an educational program (NGAYDAUTIEN) in comparison to hypertensive patients initiating other antihypertensive drugs (except single pill combination).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Aged of at least 18 years (without upper limit of age)
- •Diagnosis of grade 1 or grade 2 hypertension
- •Naïve of treatment:
- •newly diagnosed hypertension and without treatment with antihypertensive effect for at least 3 months
- •previously diagnosed but without treatment with antihypertensive effect for at least 3 months
- •Patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period
排除标准
- •Previously attended to the Ngay Dau Tien educational program for HBP management
- •Plan to be hospitalized for other medical conditions during the next 6 months
- •Plan to move/relocate during 6-month follow-up
- •Have a severe disease (i.e. cirrhosis, end-stage renal disease ...)
- •Are unlikely to cooperate in the study
- •Arm 1: patient having contra-indication to take Viacoram® according to SmPC
- •Arm 2: patient showing interest in attending NDT educational program.
结局指标
主要结局
change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 arms
时间窗: from baseline to 6-month follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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