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

February 3, 2022 updated by: Organon and Co

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3834

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan 50 mg
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)
Drug: Losartan 50 mg
50-mg losartan oral tablet
Other Names:
  • Losartan potassium
Experimental: Losartan 150 mg
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
Drug: Losartan 150 mg
100-mg losartan oral tablet + 50-mg losartan oral tablet
Other Names:
  • Losartan potassium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Entire follow-up (median = 4.7 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.
Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause)
Time Frame: Entire follow-up (median = 4.7 years)
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)
Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization
Time Frame: Entire follow-up (median = 4.7 years)
Entire follow-up (median = 4.7 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2001

Primary Completion (Actual)

March 31, 2009

Study Completion (Actual)

May 13, 2009

Study Registration Dates

First Submitted

August 25, 2004

First Submitted That Met QC Criteria

August 26, 2004

First Posted (Estimate)

August 27, 2004

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0954-948
  • 2004_004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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