Primary Hypertension
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Southern Medical University, China
CSPC Ouyi Pharmaceutical Co., Ltd.
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of composite cardiovascular and cerebrovascular endpoints | 2 years |
| quality of blood pressure control | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| cost-effectiveness analysis | 2 years |
| Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate | 2 years |
| incidence of adverse reaction | 2 years |
Countries
China
Outcome results
None listed