Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure

This study is ongoing, but not recruiting participants.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090259

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: MK0954, losartan potassium / Duration of Treatment: 7 years	Phase III

MedlinePlus related topics: Heart Failure

Drug Information available for: Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy 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

Further study details as provided by Merck:

Primary Outcome Measures:

Composite event rate of all cause death and/or hospitalization for heart failure

Estimated Enrollment:	3656
Study Start Date:	November 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090259

Locations

United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Study ID Numbers:	2004_004
Study First Received:	August 25, 2004
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00090259
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Losartan
Heart Failure
Heart Diseases
Angiotensin II

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009