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Completed

NCT Number: NCT00090259

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan 50 mg

Drug

50-mg losartan oral tablet

Other names: Losartan potassium

Losartan 150 mg

Drug

100-mg losartan oral tablet + 50-mg losartan oral tablet

Other names: Losartan potassium

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. Number of Participants That Died (Any Cause)

    Time frame: Entire follow-up (median = 4.7 years)

  3. Number of Participants That Were Hospitalized for Heart Failure

    Time frame: Entire follow-up (median = 4.7 years)

  4. Number of Participants That Experienced Cardiovascular Hospitalization

    Time frame: Entire follow-up (median = 4.7 years)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2004
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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