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

Part of paid clinical trials in Fort Smith, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04252287
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 100 mg — DRUG
    Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
  • Placebo — DRUG
    Participants will receive matching placebo capsules orally once daily.

Study Details

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).

Key Dates

Start date
Mar 10, 2020
Status verified
Mar 2025
Primary completion
Nov 9, 2021
Completion
Nov 9, 2021

Study Design

Enrollment
476 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin 100 mg
    Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will be administered matching placebo capsules orally once daily for 12 weeks.

Primary Outcome Measure

Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Mercy Clinic Cardiology - Fort SmithFort SmithArkansas72903-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Clearwater Cardiovascular ConsultantsClearwaterFlorida33756-
Emory UniversityAtlantaGeorgia30022-
St Lukes Regional MedicalBoiseIdaho83712-
OSF HealthCare Cardiovascular InstitutePeoriaIllinois61614-
Central Dupage HospitalWinfieldIllinois60190-
Parkview Cancer InstituteFort WayneIndiana46845-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-
MedStar Health Research InstituteHyattsvilleMaryland20782-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
St. Luke's Hospital Kansas CityKansas CityMissouri64111-
Mercy Health ResearchWashingtonMissouri63090-
Robert Wood Johnson Medical School Dept. of MedicinePiscatawayNew Jersey08854-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Thomas Spann ClinicCorpus ChristiTexas78412-
Texas Heart InstituteHoustonTexas77030-

Find similar trials in Fort Smith, AR

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Mercy Clinic Cardiology - Fort Smith· Fort Smith, ARUniversity of Colorado Anschutz Medical Campus· Aurora, COClearwater Cardiovascular Consultants· Clearwater, FLEmory University· Atlanta, GASt Lukes Regional Medical· Boise, IDOSF HealthCare Cardiovascular Institute· Peoria, IL

Related Studies