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Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)

Primary Purpose

Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0954, /Duration of Treatment : 5 Years
Comparator : atenolol /Duration of Treatment : 5 Years
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 55 to 80 years Males and females Hypertension (160-200/95-115 mm Hg ECG evidence of left ventricular hypertrophy Exclusion Criteria: Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers Myocardial infarction or stroke within 6 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)

    Secondary Outcome Measures

    cardiovascular death, stroke, myocardial infarction, all-cause mortality, hospitalization for heart failure, new-onset diabetes mellitus

    Full Information

    First Posted
    June 15, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338260
    Brief Title
    Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)
    Official Title
    A Triple-Blind, Parallel Study to Investigate the Effect of Losartan Versus Atenolol on the Reduction of Morbidity and Mortality in Hypertensive Patients With Left Ventricular Hypertrophy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1995 (undefined)
    Primary Completion Date
    September 2001 (Actual)
    Study Completion Date
    November 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with high blood pressure and thickening of the main pumping chamber of the heart. The results showed that after an average treatment time of 4.8 years, treatment that was based on losartan was better than treatment based on atenolol for reducing the risk of having a stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    496 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0954, /Duration of Treatment : 5 Years
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator : atenolol /Duration of Treatment : 5 Years
    Primary Outcome Measure Information:
    Title
    Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)
    Secondary Outcome Measure Information:
    Title
    cardiovascular death, stroke, myocardial infarction, all-cause mortality, hospitalization for heart failure, new-onset diabetes mellitus

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 55 to 80 years Males and females Hypertension (160-200/95-115 mm Hg ECG evidence of left ventricular hypertrophy Exclusion Criteria: Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers Myocardial infarction or stroke within 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11937178
    Citation
    Dahlof B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristiansson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H; LIFE Study Group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002 Mar 23;359(9311):995-1003. doi: 10.1016/S0140-6736(02)08089-3.
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    Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)

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