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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090259
First received: August 25, 2004
Last updated: October 25, 2013
Last verified: October 2013

August 25, 2004
October 25, 2013
December 2001
August 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) ] [ Designated as safety issue: No ]
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) ] [ 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 ]
Not Provided
Not Provided
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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)(COMPLETED)
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3834
August 2009
August 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00090259
0954-948, 2004_004
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

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