Levamlodipine Maleate or Amlodipine Besylate for Treatment of Hypertension: A Comparative Effectiveness Research

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (Norvasc) in treatment of hypertension in a Chinese primary hypertension population.

Detailed Description
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It is a multicenter, prospective cohort study with large sample size. It is to evaluate the effect on the incidence of cardiovascular and cerebrovascular endpoint events and blood pressure control in hypertensive patients who use Levamlodipine Maleate (Xuanning) or amlodipine besylate(Norvasc).Xuanning group and Norvasc group will recruit 5000 patients respectively. Each site will recruit patients in chronological order；patients who participate will finish the two-year follow up(1,2,3,6,12,18,24 months after recruitment) and relevant data will be recorded. Baseline data will be analyzed to evaluate the equilibrium between two or more groups (such as the number of options). Logistic regression and propensity scores (PS) would be used to match major indicators of effectiveness and safety indicators using matching method baseline data.

Official Title
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Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research

Conditions
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Primary Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systolic pressure ≥140mmHg or diastolic pressure ≥90mmHg or receiving antihypertensive drug treatment Patient himself/herself or his/her family member has already signed the informed consent form Patient is fit for use of Levamlodipine Maleate or amlodipine besylate Age≥45 Exclusion Criteria: patient with secondary hypertension patients who has suffered from myocardial infarction or stroke within the latest 3 months patients who has obvious intelligence、hearing and limb's activity disability Patients with severe disease, with a life expectancy of less than two years

Ages Eligible for Study
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Minimum Age: 45 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Levamlodipine Maleate (Xuanning)<br>Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications | |
| Amlodipine Besylate (Norvasc)<br>Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of composite cardiovascular and cerebrovascular endpoints |  | 2 years | 
| quality of blood pressure control |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse reaction |  | 2 years | 
| cost-effectiveness analysis |  | 2 years | 
| Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate |  | 2 years |