NCT02031861已完成4 期
Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- change in morning blood pressure surge from baseline
研究概览
简要总结
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential 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
- None
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
- •Voluntarily participate and must sign informed consent form
- •Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
- •Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg
排除标准
- •Secondary hypertension and malignant hypertension
- •Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
- •Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
- •Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
- •Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
- •Kock pouch
- •Sever gastrointestinal stenosis
- •Abnormal laboratory values with clinical significance, including serum potassium <3.5 or >5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) >2-fold upper limit of normal (ULN), Cr >ULN
- •Uric acid >ULN with the diagnosis of gout
- •Gastrointestinal abnormalities or surgery that may interfere with drug absorption
- •Hyperthyroidism or hypothyroidism
- •Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
- •Heavy smokers (>25 cigarettes every day), alcoholics (>250 ml liquor every day), drug addicts
- •Psychological diseases, acrasia, cannot express explicitly
- •Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
- •Anxiety disorders, depression or cannot follow study protocol
- •Night shift, irregular sleep patterns or insomnia
- •participate in other clinical trials within 3 months
- •other conditions that investigators consider unsuitable for participation
研究组 & 干预措施
nifedipine CR tablets (Adalat)
Active Comparator
Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.
干预措施: nifedipine CR tablets (Adalat) (Drug)
nifedipine CR tablets (Xin Ran)
Experimental
Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.
干预措施: nifedipine CR tablets (Xin Ran) (Drug)
结局指标
主要结局
change in morning blood pressure surge from baseline
时间窗: 12 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
时间窗: 12 weeks
次要结局
- smoothness index(8 weeks)
- change in morning blood pressure surge from baseline(8 weeks)
- change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline(8 weeks)
- change in systolic blood pressure (SBP) from baseline(12 weeks)
- change in diastolic blood pressure (DBP) from baseline(12 weeks)
- change in morning blood pressure from baseline(8 weeks)
- T/P ratio(8 weeks)
- average reduction in systolic blood pressure from 18 to 24 hours after administration(8 weeks)
- average reduction in diastolic blood pressure from 18 to 24 hours after administration(8 weeks)
研究者
研究点 (1)
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