Efficacy, Safety and Cost effectiveness of Telmisartan and Cilnidipine in Hypertensive Patients with coronary artery disease in a tertiary care hospital.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- SRM
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Primary objective is to evaluate the SBP and DBP as compared to baseline of telmisartan and Cilnidipine
研究概览
简要总结
Hypertension is the major risk factor for cardiovascular mortality. One of the important elements in hypertension control is early diagnosis. Reduction in blood pressure by 5mmHg can decrease the risk of Stroke by 34%, Ischemic Heart Disease by 21% reduce dementia, heart failure and mortality from Cardiovascular
disease. Telmisartan is a long acting Angiotensin Receptor Blocker (ARB), which has affinity for AT1 receptors. The pharmacokinetic of Telmisartan is having a long
half life of 24 hours, good penetration due to large volume of distribution and minimal renal clearance compared to other ARB’s. Cilnidipine is an intermediate acting
dihydropyridine. It is given in patients with isolated systolic hypertension and is renoprotective. Hence this study is taken to evaluate the efficacy and safety of
Telmisartan and Cilnidipine in hypertensive patients with Coronary Artery Disease. Blood pressure is decreased significantly in both the groups and there was decrease
in heart rate in patients taking Cilnidipine. The pharmacoeconomic factors will be taken into consideration to derive a cost effective regime, so that patients can
continue the medications for a long term for better therapeutic outcome.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients 18-80 years of age.
- •2.Known hypertensive patients with coronary artery disease 3.Range of blood pressure in >140/90mmHg 4.Hypertensive patients with co morbidity conditions like Diabetes mellitus, Dyslipidemia.
排除标准
- •1.Age below 18 years and above 80 years 2.Pregnant and lactating women.
- •3.Patients with hepatic impairment.
- •4.Patients with acute illness or blood pressure >180mmHg systolic or >120mmHg diastolic 5.Known hypersensitivity to telmisartan/cilnidipine.
结局指标
主要结局
Primary objective is to evaluate the SBP and DBP as compared to baseline of telmisartan and Cilnidipine
时间窗: The blood pressure readings will be noted on Day 0, 4 weeks, 12 weeks and the end of 6 months
次要结局
- To compare the parameters between two groups in hypertensive patients. Samples are collected from patients and tested for Blood urea and Serum Creatinine, Sodium, Potassium, Chloride and Bicarbonate.