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Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

NCT03036124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4744

Last updated 2020-09-01

Study results available
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Summary

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Conditions

  • Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

DRUG

Dapagliflozin

10 mg or 5 mg tablets given once daily, per oral use.

DRUG

Placebo

Placebo matching dapagliflozin 10 mg or 5 mg.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • India
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • Sweden
  • Taiwan
  • United Kingdom
  • Vietnam

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 NCT03036124 on ClinicalTrials.gov