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NCT02107092 · ClinicalTrials.gov registry record · Phase 3
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
A Phase 3 study, sponsored by ZS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
NCT02107092 is a Phase 3 study that has completed, run by ZS Pharma. The registered enrollment target is 123 participants.
The verdict
NCT02107092, a Phase 3 study, has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
Study Summary
Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.
Interventions
- DRUG Sodium Zirconium Cyclosilicate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2015-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02107092
The ClinicalTrials.gov registry entry for NCT02107092 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZS Pharma, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium Zirconium Cyclosilicate is the first listed.
NCT02107092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02107092 about?
NCT02107092 is a clinical study titled "Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.". Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium...
What is the current status of trial NCT02107092?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2014-05-31. Estimated completion is 2015-08-31.
What interventions are being tested in trial NCT02107092?
The interventions under investigation include: Sodium Zirconium Cyclosilicate (DRUG).
Who is sponsoring clinical trial NCT02107092?
This trial is sponsored by ZS Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
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