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

NCT01844570 | Unknown

• 1 other identifier: LEADER
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hypertension

Outcome Measures

Primary Outcomes (2)

• incidence of composite cardiovascular and cerebrovascular endpoints

  2 years

• quality of blood pressure control

  2 years

Secondary Outcomes (3)

• 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

Study Arms (2)

Levamlodipine Maleate (Xuanning)

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

Amlodipine Besylate (Norvasc)

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator
• Southern Medical University, China: collaborator
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (1)

• 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.

  PMID: 32915349 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong Huo, MD

  Department of Cardiology, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of cardiovascular medicine

Study Record Dates

• First Submitted: April 28, 2013
• First Posted: May 1, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

CN (1)