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

Sponsor:	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: Losartan 50 mg Drug: Losartan 150 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Potassium

Drug Information available for: Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.
Number of Participants That Died (Any Cause) [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
Number of Participants That Were Hospitalized for Heart Failure [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
Number of Participants That Experienced Cardiovascular Hospitalization [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]

Enrollment:	3834
Study Start Date:	October 2001
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Losartan potassium

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. Epub 2009 Nov 16.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00090259 History of Changes
Other Study ID Numbers:	2004_004, MK0954-948
Study First Received:	August 25, 2004
Results First Received:	June 30, 2010
Last Updated:	October 21, 2010
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012