MedTrace Logo

A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure

NCT04252287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476

Last updated 2025-03-30

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).

Conditions

Interventions

DRUG

Canagliflozin 100 mg

Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.

DRUG

Placebo

Participants will receive matching placebo capsules orally once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2021-11-09
Completion
2021-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04252287 on ClinicalTrials.gov