A Multicentric, Prospective, Double blind, Randomized, Comparative Clinical trial to evaluate the Efficacy and Tolerability of Efonidipine in the treatment of Hypertension

Zuventus Healthcare Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients aged 18 to 65 years
•2.Patients with stage 1 hypertension as per Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII)
•3.Patients with heart rate > 83 beats/min
•4.Patients ready to sign informed consent

•1.Patients with severe hypertension with sitting systolic BP >= 180 mm Hg
•2.Patients with history of stroke or myocardial infarction in the previous 6 months
•3.Patients with congestive heart failure, sick sinus syndrome or sinus bradycardia ( < 50 beats/min)
•4.Patients with second- or third-degree atrioventricular block
•5.Patients with documented hypersensitivity to dihydropyridine CCBs
•6.Patients with hepatic disease with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper normal limit
•7.Patients with renal disease with a serum creatinine concentration > 2.0 mg/dL
•8.Patients with uncontrolled diabetes, (hemoglobin A1C > 9%), renal artery stenosis, or secondary hypertension
•9.Pregnant women or nursing mothers
•10.Females with child bearing potential (considerations relate to choice of contraception, planning for pregnancy and overall obstetric care during pregnancy)
•11.Patients with history of alcohol dependence, alcohol abuse or drug abuse
•12.Patients with history of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form)
•13.Patients scheduled for surgery anytime during the study
•14.Patient receiving some other drug during the study besides that in the protocol that could possibly alter the bio availability of the drug
•15.The patient previously been participated in any other clinical trial within the last month

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