Heart FailurePhase 3NCT00090259

Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)

A Phase 3 study testing Losartan 50 mg and Losartan 150 mg in people with Heart Failure, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Losartan 50 mg and Losartan 150 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,834 participants
Where: No sites listed yet
Study dates: 19 Dec 2001to 13 May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
May or may not be receiving an alternative and/or additional drug treatment

Who cannot join

None listed.

About this study

Official title: A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment

This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.

Conditions: Heart Failure
Being tested: Losartan 50 mg, Losartan 150 mg
Medical subject headings: Heart Failure

What participants receive

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

Losartan 50 mgDrug
Also called Losartan potassium
50-mg losartan oral tablet
Losartan 150 mgDrug
Also called Losartan potassium
100-mg losartan oral tablet + 50-mg losartan oral tablet

Study groups in NCT00090259
Study group	Role	What they receive
Losartan 50 mg	Experimental	50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years) Receives: Drug: Losartan 50 mg
Losartan 150 mg	Experimental	Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan Receives: Drug: Losartan 150 mg

What is being measured

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

Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure
Measured: Entire follow-up (median = 4.7 years)

Secondary outcomes (4)

Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization
Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.
Measured: Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause)
Measured: Entire follow-up (median = 4.7 years)
Number of Participants That Were Hospitalized for Heart Failure
Measured: Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization
Measured: Entire follow-up (median = 4.7 years)

Timeline

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

19 Dec 200113 May 2009

First posted27 Aug 2004 (estimated)
Study start19 Dec 2001
Primary completion31 Mar 2009
Study completion13 May 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,834 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090259
Sponsor's protocol ID: 0954-948
Other IDs: 2004_004
Status last verified: Feb 2022
First submitted: 25 Aug 2004
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
PubMed 27514751
Rossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.
PubMed 25828348
Kiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.
PubMed 25742759
Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.
PubMed 19922995

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment
ClinicalTrials.gov ID: NCT00090259
Acronym / sponsor ID: 0954-948
Conditions: Heart Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,834 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 19 Dec 2001 (actual)
Primary completion: 31 Mar 2009 (actual)
Study completion: 13 May 2009 (actual)
First posted: 27 Aug 2004 (estimated)
Results: Posted 2 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Losartan 50 mg	Experimental	Drug: Losartan 50 mg50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)
Losartan 150 mg	Experimental	Drug: Losartan 150 mgTitrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
May or may not be receiving an alternative and/or additional drug treatment

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Losartan 50 mgAlso: Losartan potassium50-mg losartan oral tablet	Drug	Losartan 50 mg
Losartan 150 mgAlso: Losartan potassium100-mg losartan oral tablet + 50-mg losartan oral tablet	Drug	Losartan 150 mg

Primary outcome

Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure
Time frame: Entire follow-up (median = 4.7 years)

4 secondary outcomes

Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization
Time frame: Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause)
Time frame: Entire follow-up (median = 4.7 years)
Number of Participants That Were Hospitalized for Heart Failure
Time frame: Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization
Time frame: Entire follow-up (median = 4.7 years)

Results and safety

Results posted to the registry on 2 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan 50 mg	1,913	1,851
Losartan 150 mg	1,921	1,873

Primary outcome: Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure

Time frame: Entire follow-up (median = 4.7 years). Number. Unit: Participants

Measure	Losartan 50 mg n = 1913	Losartan 150 mg n = 1921
Value	889	828

Losartan 50 mg vs Losartan 150 mg: Hazard Ratio (HR): 0.899 (95% CI 0.818 to 0.988), p = 0.027, Regression, Cox

Population analysed: Intention-to-Treat

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse experiences that occurred during or up to 14 days after permanent or temporary discontinuation of the study treatment were included in the safety analyses. Per guidelines, endpoints were not reported as serious adverse experiences.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan 50 mg	691 of 1,913 (36.1%)	1,358 of 1,913 (71%)	Not reported
Losartan 150 mg	710 of 1,921 (37%)	1,394 of 1,921 (72.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27514751Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
Derived from this study: PubMed 25828348Rossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.
Derived from this study: PubMed 25742759Kiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.
Derived from this study: PubMed 19922995Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.
Individual participant dataSharing planned: No

Related trials for Heart Failure

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Losartan 50 mg and Losartan 150 mg in people with Heart Failure, 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 2 inclusion and 0 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 16 May 2024. 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?

Yes. Results are posted in the registry (first posted 2 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure (time frame: Entire follow-up (median = 4.7 years)). 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 NCT00090259, which also lists 4 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 16 May 2024.