ASSESSMENT OF THE EFFICACY AND TOLERABILITY OF A FIXED-DOSECOMBINATION OF METOPROLOL AND AMLODIPINE IN ESSENTIALHYPERTENSIO

Dr.Reddy's Laboratories Ltd,Ameerpet, Hyderabad-5000160 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Patients of either sex aged between 18 to 75 with mild to moderate essential hypertension who are drug naïve or have
•not shown response to dietary and lifestyle modification or previous therapy (if different from study drug regimen).
•Hypertensive Patients with CAD/ CAD equivalents.
•The blood pressure cut offs for inclusion are: ≥ 140/90 mmHg & < 180/110mmHg.
•In isolated systolic hypertension, the blood pressure cut off for inclusion is SBP of ≥140.

•1)An absolute contraindication / intolerance or hypersensitivity reaction to any of the components in the combination
•2) The physician is of the opinion that changing a patient's medication would put the patient at risk (e.g. high dose beta-blocker required to manage anginal symptoms or for rate control in atrial fibrillation, accelerated/ severe malignant hypertension, severe obstructive coronary artery disease, cardiac failure,
•uncontrolled diabetes mellitus, severe renal insufficiency)
•3) Recent (within 6 months) myocardial infarction or stroke
•4) Acute medical conditions/ surgeries
•5) Medical/ psychiatric conditions likely to hinder trial process
•6) Pregnancy and lactation
•7) Women of reproductive age, not practicing contraception.
•8) Hepatic dysfunction (AST/ALT/AlkPO4) level more than 3 times upper limit of
•normal/ Bilirubin greater than 1.5 times upper limit of normal (ULN)/ Known
•hepatic cirrhosis)
•9) Renal dysfunction (any of the renal function tests more than 3 times the upper
•limit of normal)
•10) Concurrent immunosuppressive or antineoplastic therapy
•11) Drug or alcohol abuse
•12) Treatment with another investigational drug of less than 30 days since prior to
•13) Prior enrolment in the same trial
•14) Patients unwilling to give written informed consent

发起方

Dr.Reddy's Laboratories Ltd,Ameerpet, Hyderabad-500016