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临床试验/CTRI/2019/01/017089
CTRI/2019/01/017089招募中不适用

A prospective, observational, Multicenter study to evAluate safety and effIcacy of cilniDipine, mEtoprolol succinate and chlorthalidoNe in high risk hypertensive patients

Aprica Healthcare Pvt Ltd7 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
7
主要终点
1. Reduction in Mean Systolic blood pressure

研究概览

简要总结

This is prospective, observational data collection study of the high risk hypertensive patients visiting various clinics across India. High risk hypertensive patients are generally prescribed more than one antihypertensive drugs. We plan to enroll approximately 500 patients from approximately 25 different clinics receiving treatment of cilnidipine, metoprolol succinate and chlorthalidone. The primary objective of the study is to evaluate reduction in systolic and diastolic blood pressure along with treatment emergent complications and secondary objective of the study is to understand demography, Socioeconomic status of patient, Comorbid conditions, Preferred Dose of cilnidipine, metoprolol succinate and chlorthalidone and associated adverse effects.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing to provide written informed consent form 2.Male or Female patients aged 18 years and above 3.Essential hypertension which is uncontrolled (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg ) on dual anti-hypertensive agents 4.Patients treated with cilnidipine, metoprolol succinate and chlorthalidone.

排除标准

  • Patients receiving any other antihypertensive other than cilnidipine, metoprolol succinate and chlorthalidone.

结局指标

主要结局

1. Reduction in Mean Systolic blood pressure

时间窗: 1, 3 and 6 months

2. Reduction in Mean Diastolic blood pressure

时间窗: 1, 3 and 6 months

3. Complications

时间窗: 1, 3 and 6 months

次要结局

  • 1.Demographic data of study participants(2.Socioeconomic status of patient)

研究者

发起方
Aprica Healthcare Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (7)

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