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NCT04252287 · ClinicalTrials.gov registry record · Phase 3
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 476
- Enrollment target
NCT04252287: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT04252287 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 476 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04252287, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 476 participants
- Enrollment target
Study 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).
Primary Outcome
Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social l
Interventions
- DRUG Placebo
- DRUG Canagliflozin 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2021-11-09 |
| Phase | Phase 3 |
What the finished NCT04252287 record still lists
NCT04252287 is an interventional study that assigns participants to a tested intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04252287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04252287 about?
NCT04252287 is a clinical study titled "A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure". 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).
What is the current status of trial NCT04252287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 476 participants. The study started on 2020-03-10. Estimated completion is 2021-11-09.
What interventions are being tested in trial NCT04252287?
The interventions under investigation include: Placebo (DRUG), Canagliflozin 100 mg (DRUG).
Who is sponsoring clinical trial NCT04252287?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04252287's enrollment target sits among peer trials
476 808th of 2000 higher than 1,193 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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