Clinical trial NCT01844570: Levamlodipine Maleate or Amlodipine Besylate for Treatment of Hypertension: A Comparative Effectiveness Research
Official title: Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Hypertension
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
name: Southern Medical University, China
name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2013-05-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of composite cardiovascular and cerebrovascular endpoints
timeFrame: 2 years
measure: quality of blood pressure control
timeFrame: 2 years
Secondary outcomes:
measure: incidence of adverse reaction
timeFrame: 2 years
measure: cost-effectiveness analysis
timeFrame: 2 years
measure: Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Department of Cardiology, Peking University First Hospital
name: Yong Huo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.