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