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NCT05422131

Clozapine Therapy Sample Collection - Method Comparison Study

Completed Last updated 18 May 2023
What this trial tests

trial testing MyCare Insite Clozapine Test in Patients Prescribed Clozapine in 153 participants. Completed in 16 May 2023.

Timeline
12 November 2022
Primary endpoint
25 January 2023
16 May 2023

Quick facts

Lead sponsorSaladax Biomedical, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment153
Start date12 November 2022
Primary completion25 January 2023
Estimated completion16 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Saladax Biomedical, Inc.

Who can join

21 and older, any sex, with Patients Prescribed Clozapine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Saladax Biomedical, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05422131.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing