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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090259
First Posted: August 27, 2004
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
August 25, 2004
August 27, 2004
June 30, 2010
August 2, 2010
May 5, 2017
December 19, 2001
March 31, 2009   (Final data collection date for primary outcome measure)
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) ]
Not Provided
Complete list of historical versions of study NCT00090259 on ClinicalTrials.gov Archive Site
  • 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.
  • Number of Participants That Died (Any Cause) [ Time Frame: Entire follow-up (median = 4.7 years) ]
  • Number of Participants That Were Hospitalized for Heart Failure [ Time Frame: Entire follow-up (median = 4.7 years) ]
  • Number of Participants That Experienced Cardiovascular Hospitalization [ Time Frame: Entire follow-up (median = 4.7 years) ]
Not Provided
Not Provided
Not Provided
 
Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Heart Failure
  • Drug: Losartan 50 mg
    50-mg losartan oral tablet
    Other Name: Losartan potassium
  • Drug: Losartan 150 mg
    100-mg losartan oral tablet + 50-mg losartan oral tablet
    Other Name: Losartan potassium
  • 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)
    Intervention: Drug: Losartan 50 mg
  • 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
    Intervention: Drug: Losartan 150 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3834
May 13, 2009
March 31, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00090259
0954-948
2004_004
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP