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NCT04676646 · ClinicalTrials.gov registry record · Phase 4
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
A Phase 4 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 4
- Development phase
- 366
- Enrollment target
NCT04676646: Completed Phase 4 study, sponsored by AstraZeneca.
NCT04676646 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 366 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04676646, a Phase 4 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 366 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
Primary Outcome
The median percentages of participants having a response are presented. Response means all three requirements were met. Non-response was indicated for participants lost to follow-up, including death. The treatment effect was analysed using a generalised estimating equation (GEE) model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label pe
Interventions
- DRUG Placebo
- DRUG Sodium zirconium cyclosilicate
- OTHER Spironolactone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 4 |
What the finished NCT04676646 record still lists
NCT04676646 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04676646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04676646 about?
NCT04676646 is a clinical study titled "Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone". The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
What is the current status of trial NCT04676646?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 366 participants. The study started on 2021-03-08. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT04676646?
The interventions under investigation include: Placebo (DRUG), Sodium zirconium cyclosilicate (DRUG), Spironolactone (OTHER).
Who is sponsoring clinical trial NCT04676646?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04676646's enrollment target sits among peer trials
366 225th of 2000 higher than 1,776 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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