Phase 3 N=3,834 Randomized Double-blind Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT00090259 ↗

Enrolled (actual)

3,834

Serious AEs

36.5%

Results posted

Aug 2010

Primary outcome: Primary: Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure — 889; 828 Participants — p=0.027

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Losartan 50 mg (Drug); Losartan 150 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure	889; 828	0.027 sig
SECONDARY Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization	1085; 1037	0.068
SECONDARY Number of Participants That Died (Any Cause)	665; 635	0.235
SECONDARY Number of Participants That Were Hospitalized for Heart Failure	503; 450	0.025 sig
SECONDARY Number of Participants That Experienced Cardiovascular Hospitalization	826; 762	0.023 sig

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.