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

Primary Hypertension Clinical Trial

— LEADER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01844570
• Other study ID #: LEADER
• Status: Active, not recruiting
• Phase: N/A
• First received: April 28, 2013
• Last updated: April 30, 2013
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Primary Hypertension

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University First Hospital	CSPC Ouyi Pharmaceutical Co., Ltd., Ministry of Science and Technology of the People´s Republic of China, Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of composite cardiovascular and cerebrovascular endpoints		2 years	No
Primary	quality of blood pressure control		2 years	No
Secondary	incidence of adverse reaction		2 years	Yes
Secondary	cost-effectiveness analysis		2 years	No
Secondary	Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate		2 years	No