Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure

Study Overview
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Brief Summary
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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 Early Morning Blood Pressure and Central Arterial Pressure.

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: nifedipine CR tablets (Xin Ran)
* Drug: Adalat


Participation Criteria
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Eligibility Criteria
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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) The mean morning blood press of one week >135/85 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nifedipine CR tablets (Xin Ran)<br>Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 8-week treatment period. | Drug: nifedipine CR tablets (Xin Ran)<br> <br> |
| Active Comparator: nifedipine CR tablets (Adalat)<br>Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 8-week treatment period. | Drug: Adalat<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline | early morning blood pressure mean systolic and diastolic pressure measured by Omron-7080-IC calculated as the mean of all of the early morning blood pressure mean systolic and diastolic pressure measurements for 7 consecutive days after 8 weeks. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central systolic blood pressure from baseline . |  | 8 weeks | 
| change in central diastolic blood pressure from baseline . |  | 8 weeks | 
| change in central pulse pressure from baseline . |  | 8 weeks | 
| change in augmentation index from baseline . |  | 8 weeks | 
| change in mean systolic and diastolic pressure from baseline |  | 8 weeks |