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NCT01737697 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
A Phase 3 study, sponsored by ZS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 754
- Enrollment target
NCT01737697 is a Phase 3 study that has completed, run by ZS Pharma. The registered enrollment target is 754 participants.
The verdict
NCT01737697, a Phase 3 study, has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 754 participants
- Enrollment target
Study Summary
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).
Interventions
- DRUG Zirconium silicate (acute phase)
- DRUG Zirconium silicate (subacute phase)
- DRUG Placebo (acute phase)
- DRUG Placebo ( subacute phase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 754 participants |
| Start Date | 2012-11-30 |
| Est. Completion | 2013-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01737697
The ClinicalTrials.gov registry entry for NCT01737697 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 754 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 4 interventions - of which Zirconium silicate (acute phase) is the first listed.
NCT01737697 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01737697 about?
NCT01737697 is a clinical study titled "Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia". Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Subacute Phase (randomized withdra...
What is the current status of trial NCT01737697?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 754 participants. The study started on 2012-11-30. Estimated completion is 2013-11-30.
What interventions are being tested in trial NCT01737697?
The interventions under investigation include: Zirconium silicate (acute phase) (DRUG), Zirconium silicate (subacute phase) (DRUG), Placebo (acute phase) (DRUG), Placebo ( subacute phase) (DRUG).
Who is sponsoring clinical trial NCT01737697?
This trial is sponsored by ZS Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
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