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Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)Phase 3NCT00338260

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

A Phase 3 study testing MK0954, /Duration of Treatment : 5 Years and Comparator : atenolol /Duration of Treatment : 5 Years in people with Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart), run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 80 years
What is being tested?
MK0954, /Duration of Treatment : 5 Years and Comparator : atenolol /Duration of Treatment : 5 Years
How many people
496 participants
Where
No sites listed yet
Study dates
Jun 1995to Nov 2001
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 55 to 80 years
  • Males and females
  • Hypertension (160-200/95-115 mm Hg
  • ECG evidence of left ventricular hypertrophy

Who cannot join

  • Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers
  • Myocardial infarction or stroke within 6 months

About this study

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

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.

Being tested
MK0954, /Duration of Treatment : 5 Years, Comparator : atenolol /Duration of Treatment : 5 Years
Medical subject headings
Hypertension, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK0954, /Duration of Treatment : 5 YearsDrug

  • Comparator : atenolol /Duration of Treatment : 5 YearsDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2006 (estimated)
  2. Study startJun 1995
  3. Primary completionSep 2001
  4. Study completionNov 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
496 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338260
Sponsor's protocol ID
0954-133
Other IDs
2006_502
Status last verified
Feb 2022
First submitted
15 Jun 2006
Last updated
15 Feb 2022
Results posted
No

Publications

  • 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.

    PubMed 11937178

  • Lindholm LH, Ibsen H, Dahlof B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn S; LIFE Study Group. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002 Mar 23;359(9311):1004-10. doi: 10.1016/S0140-6736(02)08090-X.

    PubMed 11937179

  • Devereux RB, Dahlof B, Gerdts E, Boman K, Nieminen MS, Papademetriou V, Rokkedal J, Harris KE, Edelman JM, Wachtell K. Regression of hypertensive left ventricular hypertrophy by losartan compared with atenolol: the Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial. Circulation. 2004 Sep 14;110(11):1456-62. doi: 10.1161/01.CIR.0000141573.44737.5A. Epub 2004 Aug 23.

    PubMed 15326072

  • Okin PM, Devereux RB, Jern S, Kjeldsen SE, Julius S, Nieminen MS, Snapinn S, Harris KE, Aurup P, Edelman JM, Dahlof B; Losartan Intervention for Endpoint reduction in hypertension Study Investigations. Regression of electrocardiographic left ventricular hypertrophy by losartan versus atenolol: The Losartan Intervention for Endpoint reduction in Hypertension (LIFE) Study. Circulation. 2003 Aug 12;108(6):684-90. doi: 10.1161/01.CIR.0000083724.28630.C3. Epub 2003 Jul 28.

    PubMed 12885747

  • Wachtell K, Hornestam B, Lehto M, Slotwiner DJ, Gerdts E, Olsen MH, Aurup P, Dahlof B, Ibsen H, Julius S, Kjeldsen SE, Lindholm LH, Nieminen MS, Rokkedal J, Devereux RB. Cardiovascular morbidity and mortality in hypertensive patients with a history of atrial fibrillation: The Losartan Intervention For End Point Reduction in Hypertension (LIFE) study. J Am Coll Cardiol. 2005 Mar 1;45(5):705-11. doi: 10.1016/j.jacc.2004.06.080.

    PubMed 15734614

  • Ibsen H, Wachtell K, Olsen MH, Borch-Johnsen K, Lindholm LH, Mogensen CE, Dahlof B, Devereux RB, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wan Y; LIFE substudy. Does albuminuria predict cardiovascular outcome on treatment with losartan versus atenolol in hypertension with left ventricular hypertrophy? A LIFE substudy. J Hypertens. 2004 Sep;22(9):1805-11. doi: 10.1097/00004872-200409000-00026.

    PubMed 15311110

  • Kjeldsen SE, Dahlof B, Devereux RB, Julius S, Aurup P, Edelman J, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristianson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Snapinn S, Wedel H; LIFE (Losartan Intervention for Endpoint Reduction) Study Group. Effects of losartan on cardiovascular morbidity and mortality in patients with isolated systolic hypertension and left ventricular hypertrophy: a Losartan Intervention for Endpoint Reduction (LIFE) substudy. JAMA. 2002 Sep 25;288(12):1491-8. doi: 10.1001/jama.288.12.1491.

    PubMed 12243636

  • Lindholm LH, Ibsen H, Borch-Johnsen K, Olsen MH, Wachtell K, Dahlof B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristianson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman JM, Snapinn S; LIFE study group. Risk of new-onset diabetes in the Losartan Intervention For Endpoint reduction in hypertension study. J Hypertens. 2002 Sep;20(9):1879-86. doi: 10.1097/00004872-200209000-00035.

    PubMed 12195132

  • Devereux RB, Dahlof B, Kjeldsen SE, Julius S, Aurup P, Beevers G, Edelman JM, de Faire U, Fyhrquist F, Helle Berg S, Ibsen H, Kristianson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Snapinn S, Wedel H; LIFE Study Group. Effects of losartan or atenolol in hypertensive patients without clinically evident vascular disease: a substudy of the LIFE randomized trial. Ann Intern Med. 2003 Aug 5;139(3):169-77. doi: 10.7326/0003-4819-139-3-200308050-00006.

    PubMed 12899584

  • Wachtell K, Lehto M, Gerdts E, Olsen MH, Hornestam B, Dahlof B, Ibsen H, Julius S, Kjeldsen SE, Lindholm LH, Nieminen MS, Devereux RB. Angiotensin II receptor blockade reduces new-onset atrial fibrillation and subsequent stroke compared to atenolol: the Losartan Intervention For End Point Reduction in Hypertension (LIFE) study. J Am Coll Cardiol. 2005 Mar 1;45(5):712-9. doi: 10.1016/j.jacc.2004.10.068.

    PubMed 15734615

  • Okin PM, Gerdts E, Kjeldsen SE, Julius S, Edelman JM, Dahlof B, Devereux RB; Losartan Intervention for Endpoint Reduction in Hypertension Study Investigators. Gender differences in regression of electrocardiographic left ventricular hypertrophy during antihypertensive therapy. Hypertension. 2008 Jul;52(1):100-6. doi: 10.1161/HYPERTENSIONAHA.108.110064. Epub 2008 May 26.

    PubMed 18504323

  • Li Z, Dahlof B, Okin PM, Kjeldsen SE, Wachtell K, Ibsen H, Nieminen MS, Jern S, Devereux RB. Left bundle branch block and cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy: the Losartan Intervention For Endpoint Reduction in Hypertension study. J Hypertens. 2008 Jun;26(6):1244-9. doi: 10.1097/HJH.0b013e3282fcc23c.

    PubMed 18475164

  • Boersma C, Carides GW, Atthobari J, Voors AA, Postma MJ. An economic assessment of losartan-based versus atenolol-based therapy in patients with hypertension and left-ventricular hypertrophy: results from the Losartan Intervention For Endpoint reduction (LIFE) study adapted to The Netherlands. Clin Ther. 2007 May;29(5):963-971. doi: 10.1016/j.clinthera.2007.05.014.

    PubMed 17697915

  • Aurigemma GP, Devereux RB, Wachtell K, Palmieri V, Boman K, Gerdts E, Nieminen MS, Papademetriou V, Dahlof B. Left ventricular mass regression in the LIFE study: effect of previous antihypertensive treatment. Am J Hypertens. 2003 Mar;16(3):180-6. doi: 10.1016/s0895-7061(02)03258-2.

    PubMed 12620695

  • Boman K, Olofsson M, Dahlof B, Gerdts E, Nieminen MS, Papademetriou V, Wachtell K, Devereux RB. Left ventricular structure and function in sedentary and physically active subjects with left ventricular hypertrophy (the LIFE Study). Am J Cardiol. 2005 Jan 15;95(2):280-3. doi: 10.1016/j.amjcard.2004.09.019.

    PubMed 15642571

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK0954, /Duration of Treatment : 5 Years and Comparator : atenolol /Duration of Treatment : 5 Years in people with Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart), run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00338260, which also lists 156 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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