Clinical trial

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

Name

0954-948

Description

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.

Trial arms

Trial start

2001-12-19

Estimated PCD

2009-03-31

Trial end

2009-05-13

Status

Completed

Phase

Early phase I

Treatment

Losartan 50 mg

50-mg losartan oral tablet

Arms:

Losartan 50 mg

Other names:

Losartan potassium

Losartan 150 mg

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

Arms:

Losartan 150 mg

Other names:

Losartan potassium

Size

3834

Primary endpoint

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)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3834, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

Organon and Co

Product

Losartan

Indication

Congestive Heart Failure