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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
| Southern Medical University, China | OTHER |
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levamlodipine Maleate (Xuanning) | Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications | ||
| Amlodipine Besylate (Norvasc) | Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications |
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| Measure | Description | Time Frame |
|---|---|---|
| incidence of composite cardiovascular and cerebrovascular endpoints | 2 years | |
| quality of blood pressure control | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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100 eligible sites(including primary care clinic and tertiary hospitals) over the country will participate. Each center will collect patients who fit the recruitment standard in chronological order.
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| Name | Affiliation | Role |
|---|---|---|
| Yong Huo, MD | Department of Cardiology, Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32915349 | Derived | Ma W, Sun N, Duan C, Zhao L, Hua Q, Sun Y, Dang A, Gao P, Qu P, Cui W, Zhao L, Dong Y, Cui L, Qi X, Jiang Y, Xie J, Li J, Wu G, Du X, Huo Y, Chen P; for LEADER Study Group. Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study. Cardiovasc Drugs Ther. 2021 Feb;35(1):41-50. doi: 10.1007/s10557-020-07054-1. Epub 2020 Sep 11. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 2 years |