Essential Hypertension
Conditions
Brief summary
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.
Interventions
DRUGnifedipine CR tablets (Adalat)
Sponsors
Shanghai Shyndec Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * BMI \>30 * Night shift, irregular sleep patterns or insomnia * participate in other clinical trials within 3 months * other conditions that investigators consider unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline | 12 weeks |
| change in morning blood pressure surge from baseline | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| T/P ratio | 12 weeks |
| average reduction in systolic blood pressure from 18 to 24 hours after administration | 12 weeks |
| average reduction in diastolic blood pressure from 18 to 24 hours after administration | 12 weeks |
| smoothness index | 12 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 surge from baseline | 8 weeks |
| change in morning blood pressure from baseline | 12 weeks |
Other
| Measure | Time frame |
|---|---|
| clinical laboratory test and adverse event | 12 weeks |
Countries
China
Outcome results
None listed