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

• Conditions: Primary Hypertension

• Registration Number: NCT01844570
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-28
• Study First Submitted QC: 2013-04-30
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-01
• Last Update Posted: 2013-05-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of composite cardiovascular and cerebrovascular endpoints	2 years
quality of blood pressure control	2 years

Secondary Outcome Measures

Name	Time	Method
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	2 years

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China