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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Losartan 50 mg; Drug: Losartan 150 mg

• Registration Number: NCT00090259
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12-19
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Primary Completion: 2009-03-31
• Study Completion: 2009-05-13
• Results First Submitted: 2010-06-30
• Results First Submitted QC: 2010-06-30
• Results First Posted: 2010-08-02
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3834

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan 50 mg	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)
Losartan 150 mg	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

Primary Outcome Measures

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

Secondary Outcome Measures

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