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Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

NCT00894387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1639

Last updated 2013-11-07

Study results available
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Summary

This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Conditions

  • Acute Decompensated Heart Failure
  • Congestive Heart Failure

Interventions

DRUG

Aliskiren

Aliskiren 150 mg and Aliskiren 300 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Philippines
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894387 on ClinicalTrials.gov