A randomized, double blind, controlled clinical trial of S-Amlodipine versus conventional Amlodipine, to compare the incidence of leg edema and antihypertensive efficacy in patients with hypertension

Emcure Pharmaceuticals Limited0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

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•30-64 years of age • Diagnosed essential hypertension with either systolic BP > 140mmHg or diastolic BP > 90 mmHg or both while in the seated position • On beta blockers and ACE inhibitor /Angiotensin receptor blocker for at least 4 weeks • Consenting and willing to comply with study protocol

•Known hypersensitivity to amlodipine, calcium channel blockers or to any ingredients of the test/reference medication • Patients on calcium channel blockers or antihypertensive therapy other than ACE inhibitors or Angiotensin receptor blockers • Secondary hypertention • Clinical diagnosis of resistant or malignant hypertension • History of myocardial infarction or congestive cardiac failure • PTCA, CABG, cerebrovascular accident, or TIA in last 6 months • Diagnosed cardiac arrhythmias and/or any other abnormality on ECG • Significant respiratory /liver/ kidney/neurological diseases/ coagulation disorders • Metabolic or endocrine disorders (except Type 2 diabetes mellitus • Type 2 diabetes mellitus taking insulin or oral hypoglycemic drugs other than metformin or sulfonylurea or patients on more than one sulfonylurea • Pregnant and lactating women or women in the reproductive age group not practicing effective means of contraception. • Known alcohol or drug abuse
•Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.

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