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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00338260
First received: June 15, 2006
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)
Drug: MK0954, /Duration of Treatment : 5 Years
Drug: Comparator : atenolol /Duration of Treatment : 5 Years
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 496
Study Start Date: June 1995
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338260

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00338260     History of Changes
Other Study ID Numbers: 2006_502, MK0954-133
Study First Received: June 15, 2006
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014