NCT04457323Unknown4 期
Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.
Neutec Ar-Ge San ve Tic A.Ş0 个研究点目标入组 126 人开始时间: 2022年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 126
- 主要终点
- Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients: between the ages of 18-70,
- •Stage 1 and 2 hypertension patients who have not received any antihypertensive treatment in the past month * (≥ 140 mmHg SKB <180 mmHg, ≥ 90 mmHg DKB <110 mmHg,
- •Patients with minute heart rate ≥ 70 / min,
- •Patients followed up with outpatient treatment,
- •Patients who give written informed consent without any influence, (Stage 1 Hypertension; SKB: 140-159 mmHg and DKB: 90-99 mmHg, Stage 2 Hypertension; SKB: 160--179 mmHg and DKB: 100--109 mmHg)
排除标准
- •Pregnant patients or breastfeeding mothers or women with childbearing potential who do not use any effective contraceptive methods,
- •Patients with allergies or hypersensitivity to betabloker drugs,
- •Patients who have received antihypertensive treatment in the past month,
- •Patients with secondary hypertension,
- •Patients who were followed up for the following diseases from the beginning of the study until the last 12 months,
- •Severe hypertension (SKB> 180 mmHg and / or DKB> 110 mmHg),
- •Myocardial infarction,
- •NYHA stage 2-4 heart failure,
- •Patients with a history of cerebrovascular disease, previous ischemic attack, encephalopathy,
- •Patients undergoing percutaneous coronary intervention or coronary artery bypass surgery,
- •2nd or 3rd degree heart block or symptomatic arrhythmia without pacemaker,
- •Clinically significant heart valve disease,
- •Simultaneous life-threatening potential or symptomatic arrhythmia,
- •Simultaneous unstable angina pectoris,
- •Type 1 DM,
- •Atrial fibrillation,
- •Uncontrollable Type 2 DM (HbA1C> 7%),
- •Patients with significant liver disease (initial ALT, AST> 2xULN, esophageal varices, portocaval shunt),
- •Patients with significant kidney disease (GFR <60 ml / min according to the Cockcroft-Gault formula),
- •Patients with volume depletion,
- •Patients with pancreatic disease,
- •Patients with gastrointestinal disease affecting absorption,
- •Drug/substance and alcohol abuse in the last 12 months,
- •Patients with central nervous system disease and using drugs for this reason,
- •A history of incompatibility with medical regimens, or patients' unwillingness to comply with the study protocol,
- •Patients directly involved in the management of this protocol.
研究组 & 干预措施
Test
Experimental
S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks)
干预措施: Metoprolol (Drug)
REFERENCE
Active Comparator
Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks)
干预措施: Metoprolol (Drug)
结局指标
主要结局
Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
时间窗: 4-weeks
次要结局
- Change in systolic blood pressure between 0-8 weeks of treatment.(8-weeks)
- Change in diastolic blood pressure between 4-8 weeks of treatment.(4-weeks)
- Change in diastolic blood pressure between 0-8 weeks of treatment.(8-weeks)
- Change in sistolic blood pressure between 4-8 weeks of treatment.(8-weeks)
- Treatment response rates(4-weeks)
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