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

Sponsor
Peking University First Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01844570
Collaborator
Ministry of Science and Technology of the People´s Republic of China (Other), Southern Medical University, China (Other), CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)
10,000
Enrollment
1
Location
33.9
Duration (Months)
294.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Levamlodipine Maleate (Xuanning) or Amlodipine Besylate (Norvasc) for Treatment of Hypertension: A Comparative Effectiveness Research
    Study Start Date :
    Feb 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. incidence of composite cardiovascular and cerebrovascular endpoints [2 years]

    2. quality of blood pressure control [2 years]

    Secondary Outcome Measures

    1. incidence of adverse reaction [2 years]

    2. cost-effectiveness analysis [2 years]

    3. Explore the optimal combination of drugs for the treatment of hypertension by Levamlodipine Maleate [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University First Hospital Beijing China 100034

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Yong Huo, MD, Department of Cardiology, Peking University First Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yong Huo, Professor of cardiovascular medicine, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT01844570
    Other Study ID Numbers:
    • LEADER
    First Posted:
    May 1, 2013
    Last Update Posted:
    May 1, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension

    Study Results

    No Results Posted as of May 1, 2013