Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00338260
First received: June 15, 2006
Last updated: August 17, 2009
Last verified: August 2009
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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:
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 |
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
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: | August 17, 2009 |
| 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 Losartan 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 Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013