Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension: a Multi-center, Open-label, Observational Study
试验速览
- 阶段
- 4 期
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Control rate of hypertension evaluated by office blood pressure at 2 weeks
研究概览
简要总结
This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.
详细描述
The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg;
- •an age ≥18 and ≤75 years;
- •those who had not taken any BP-lowering medications in 1 month before the study.
排除标准
- •a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
- •secondary hypertension;
- •diagnosed heart failure or stroke;
- •Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis;
- •subjects with carotid stenosis or systolic murmur
- •subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;
- •subjects who were within lactation period, pregnant, or planning to become pregnant during the study;
- •hypersensitive to Nifedipine GITS or with SAE;
- •subjects who are participating in other clinical trials;
- •considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).
研究组 & 干预措施
Nifedipine GITS
干预措施: Nifedipine GITS (Drug)
结局指标
主要结局
Control rate of hypertension evaluated by office blood pressure at 2 weeks
时间窗: 2 weeks
Control rate of hypertension evaluated by office blood pressure at 8 weeks
时间窗: 8 weeks
Control rate of hypertension evaluated by office blood pressure at 4 weeks
时间窗: 4 weeks
次要结局
- Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks(8 weeks)
- Change of office blood pressure from baseline to 8 weeks(8 weeks)
- Change of 24-hour ABPM from baseline to 8 weeks(8 weeks)
研究者
Yong Huo
Director, Department of Cardiology
Peking University First Hospital