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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Primary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Levamlodipine Maleate (Xuanning)

Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications

No interventions assigned to this group

Amlodipine Besylate (Norvasc)

Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications

No interventions assigned to this group

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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No