NCT03038451已完成4 期
Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study
Neutec Ar-Ge San ve Tic A.Ş1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年3月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Evaluation of change in systolic blood pressure up to 4th week of the treatment
研究概览
简要总结
s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 18 years and older.
- •Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmHg MSSBP < 160 mmHg, ≥ 90 mmHg MSDBP < 100mmHg).
- •Hypertension patients controlled with single medicine.
- •Patients giving written informed consent without being under any influence.
排除标准
- •Pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method.
- •Allergy or hypersensitivity to dihydropyridines.
- •Patients receive more than one anti-hypertensive medicine.
- •Patients with seconder hypertension.
- •Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes mellitus, atrial fibrillation until the last 12 months.
- •Uncontrolled type II diabetes mellitus.
- •Patients with significant liver disease (ALT, AST must be > 2XULN in beginning, patients with esophageal varices, portacaval shunt).
- •Patients with significant kidney disease (GFR <60 ml/min according to Cockcroft-Gault formula).
- •Patients with volume depletion.
- •Patients with pancreas disease.
- •Patients with gastrointestinal disease which may effect absorption.
- •Drug/narcotic and alcohol abuse until the last 12 months.
- •Patients with central nervous system disease and taking medicine for this reason.
- •History of incompatibility with medical regimes or patients do not want to adhere the study protocol.
- •Persons directly involved in the management of this protocol.
研究组 & 干预措施
s-amlodipine besylate 2,5 and 5 mg tablets
Experimental
干预措施: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet (Drug)
结局指标
主要结局
Evaluation of change in systolic blood pressure up to 4th week of the treatment
时间窗: 4 weeks
次要结局
- Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment(4 to 8 weeks)
- Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment(4 to 8 weeks)
- Evaluation of change in systolic blood pressure up to 8th week of the treatment(8 weeks)
- Evaluation of change in diastolic blood pressure up to 8th week of the treatment(8 weeks)
- Evaluation of change in diastolic blood pressure up to 4th week of the treatment(4 weeks)
- Evaluation of treatment response rates from 4th to 8th week of the treatment(4 to 8 weeks)
研究者
研究点 (1)
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