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NCT05422131 · ClinicalTrials.gov registry record
Clozapine Therapy Sample Collection - Method Comparison Study
A clinical trial, sponsored by Saladax Biomedical.
- Completed
- Registry status
- 153
- Enrollment target
NCT05422131 is a clinical trial that has completed, run by Saladax Biomedical. The registered enrollment target is 153 participants.
The verdict
NCT05422131 has completed, sponsored by Saladax Biomedical.
- COMPLETED
- Registry status
- 153 participants
- Enrollment target
Study Summary
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
Interventions
- DEVICE MyCare Insite Clozapine Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2022-11-12 |
| Est. Completion | 2023-05-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05422131
The ClinicalTrials.gov registry entry for NCT05422131 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Saladax Biomedical, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MyCare Insite Clozapine Test is the first listed.
NCT05422131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05422131 about?
NCT05422131 is a clinical study titled "Clozapine Therapy Sample Collection - Method Comparison Study". The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psych...
What is the current status of trial NCT05422131?
This trial is currently completed. The enrollment target is 153 participants. The study started on 2022-11-12. Estimated completion is 2023-05-16.
What interventions are being tested in trial NCT05422131?
The interventions under investigation include: MyCare Insite Clozapine Test (DEVICE).
Who is sponsoring clinical trial NCT05422131?
This trial is sponsored by Saladax Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.
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