CTRI/2017/08/009242已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 22
- 主要终点
- Mean reduction in SBP and DBP from baseline to end of study
研究概览
简要总结
This is a Comparative, Randomized, Double Blind,Multicentric, Active Controlled, Parallel Group, Two Arm, Phase III ClinicalTrial to Evaluate the Efficacy, Safety and Tolerability of Fimasartan TabletsVs. Losartan Tablets in Patients with Mild Essential Hypertension. PrimaryOutcome of the study is to study the mean reduction of SBP and DBP inhypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Hypertension with SBP 140 to 159 mmHg and DBP 90 to 99 mmHg
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
排除标准
- •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.
结局指标
主要结局
Mean reduction in SBP and DBP from baseline to end of study
时间窗: Day 7, 15, 30, 60 and 90
次要结局
- Mean change in Heart Rate from baseline to end of study.(Day 7, 15, 30, 60 and 90)
研究者
研究点 (22)
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