This trial is active, not recruiting.

Condition primary hypertension
Sponsor Peking University First Hospital
Collaborator Ministry of Science and Technology of the People´s Republic of China
Start date February 2013
End date December 2015
Trial size 10000 participants
Trial identifier NCT01844570, LEADER


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Primary hypertensive patients who take Levamlodipine Maleate (Xuanning) as the only anti-hypertensive medication or one of their medications
Primary hypertensive patients who take Amlodipine Besylate (Norvasc) as the only anti-hypertensive medication or one of their medications

Primary Outcomes

incidence of composite cardiovascular and cerebrovascular endpoints
time frame: 2 years
quality of blood pressure control
time frame: 2 years

Secondary Outcomes

incidence of adverse reaction
time frame: 2 years
cost-effectiveness analysis
time frame: 2 years
Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate
time frame: 2 years

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
Principal investigator Yong Huo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Peking University First Hospital.