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
  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 3

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090259     History of Changes
Other Study ID Numbers: 0954-948, 2004_004
Study First Received: August 25, 2004
Results First Received: June 30, 2010
Last Updated: October 25, 2013
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 September 18, 2014