Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension

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 mild to moderate essential hypertension.

Official Title
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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

Conditions
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Essential Hypertension

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

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 12-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 12-week treatment period. | Drug: nifedipine CR tablets (Adalat)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in morning blood pressure surge from baseline |  | 12 weeks | 
| change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in morning blood pressure from baseline |  | 12 weeks | 
| 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 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 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 | 
| smoothness index |  | 8 weeks | 
| change in systolic blood pressure (SBP) from baseline |  | 12 weeks | 
| change in diastolic blood pressure (DBP) from baseline |  | 12 weeks |