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NCT05422131
Clozapine Therapy Sample Collection - Method Comparison Study
trial testing MyCare Insite Clozapine Test in Patients Prescribed Clozapine in 153 participants. Completed in 16 May 2023.
25 January 2023
Quick facts
| Lead sponsor | Saladax Biomedical, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 153 |
| Start date | 12 November 2022 |
| Primary completion | 25 January 2023 |
| Estimated completion | 16 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MyCare Insite Clozapine Test
Conditions studied
- Patients Prescribed Clozapine — all drugs for Patients Prescribed Clozapine →
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.
Verify or expand the search:
- PubMed search for NCT05422131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Saladax Biomedical, Inc. trials
Trials by the same sponsor.
- NCT05711732 — Busulfan Sample Collection Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05422131 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saladax Biomedical, Inc.
- Last refreshed: 18 May 2023
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