A Comparative, Randomized, Double Blind, Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan Tablets Vs. Losartan Tablets in Patients with Mild Essential Hypertension

Ajanta Pharma Ltd0 个研究点目标入组 206 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 diagnosed with Hypertension with SBP 140 to 159 mmHg and DBP 90 to 99 mmHg
•2. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

•1.Patients diagnosed with Moderate to Severe Hypertension (defined as a SBP >=160 mmHg and DBP >=100 mmHg) as defined by 6th report of JNC on Prevention, Detection, Evaluation Treatment of High Blood Pressure.
•2.Subjects who are on any other antihypertensive or diuretic drugs.
•3.Patients with severe renal impairment (eGFR <= 30ml/min).
•4.Serum potassium > 5.5 mEq/L or < 3.0 mEq/L at baseline.
•5.Patients with hepatic impairment [SGOT, SGPT and S. Bilirubin (total) >= 2 times the upper limit of normal reference values].
•6.Patients with clinical ASCVD defined as Obstructive coronary artery disease, peripheral vascular disease and Cerebrovascular disease
•7.Patients who have undergone Percutaneous Transluminal Coronary Angiography (PTCA), and Coronary Artery Bypass Graft (CABG).
•8.Patients with structural heart disease like hypertrophic obstructive cardiomyopathy, hemodynamically significant aortic valve or mitral valve disease, Pericardial diseases & CHF of any etiology.
•9.Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia.
•10.Patient with history of Type I or Type II Diabetes Mellitus

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