Metroprolol succinate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate metoprolol succinate for the management of heart failure and congestive heart failure across completed and actively recruiting studies. Supported by both industry and federal sponsors, including Novartis Pharmaceuticals and the US Department of Veterans Affairs, these protocols lack standard phase classifications, designating their trial phases as unassigned or not applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06004453	Recruiting	Heart Failure	Novartis Pharmaceuticals\|Novartis	2023-04-04	--
NCT00414401	Completed	Heart Failure Congestive	US Department of Veterans Affairs\|VA Office of Research and Development	2001-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metoprolol succinate selectively binds to and competitively antagonizes beta-1 adrenergic receptors in cardiac tissue, inhibiting catecholamine-induced adenylate cyclase activation and subsequent downstream cyclic AMP production. This reduction in beta-1 signaling decreases heart rate, myocardial contractility, and cardiac output, contributing to its therapeutic efficacy in the clinical management of congestive heart failure.

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>).