Clevidipine Butyrate Clinical Trials

Size	Price	Qty
10mg	USD 70

Clinical Trials

A Phase 4 clinical trial sponsored by Methodist Healthcare in collaboration with The Medicines Company was designed to evaluate the safety and efficacy of intravenous Clevidipine Butyrate for rapid blood pressure management in ventriculostomy patients presenting with hypertension, intracranial hemorrhage, or subarachnoid hemorrhage. Although recruitment for the study was ultimately withdrawn, the effort underscores the potential application of this dihydropyridine agent for precise blood pressure regulation in acute neurovascular settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01042574	Withdrawn	Hypertension\|Intracranial Hemorrhage\|Subarachnoid Hemorrhage	Methodist Healthcare\|The Medicines Company	2010-05	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Clevidipine Butyrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clevidipine Butyrate acts as a dihydropyridine calcium channel blocker that selectively binds to and inhibits L-type voltage-gated calcium channels, thereby preventing the influx of extracellular calcium ions into vascular smooth muscle cells. This inhibition promotes arterial vasodilation and reduces peripheral vascular resistance, providing clinical utility for rapid blood pressure control in acute hypertensive conditions, including intracranial and subarachnoid hemorrhage.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).