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

Peking University

Status: Unknown

Conditions: Primary Hypertension

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01844570

LEADER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Levamlodipine Maleate (Xuanning)

Description:

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

Amlodipine Besylate (Norvasc)

Description:

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