Carvedilol Phosphate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated carvedilol phosphate across cardiovascular and metabolic indications, focusing on hypertension, diabetes mellitus, and vascular endothelial function. GlaxoSmithKline sponsored several clinical trials that completed Phase I testing on steady-state pharmacokinetics, bioequivalence, and orthostatic hypotension risks in elderly hypertensive subjects. Additionally, the State University of New York - Downstate Medical Center initiated a clinical trial at Phase IV with unknown recruitment status to assess blood pressure regulation, endothelial function, and nitric oxide dynamics in hypertensive diabetic patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00732511	Unknown status	Endothelial Function\|Diabetes Mellitus\|Hypertension	State University of New York - Downstate Medical Center	2008-04	Phase 4
NCT00537043	Completed	Hypertension	GlaxoSmithKline	2007-10	Phase 1
NCT00552708	Completed	Hypertension	GlaxoSmithKline	2007-09	Phase 1
NCT00508365	Completed	Hypertension	GlaxoSmithKline	2007-09-25	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carvedilol phosphate non-selectively antagonizes beta-1, beta-2, and alpha-1 adrenergic receptors, thereby blocking catecholamine-mediated activation of G-protein-coupled signaling pathways and intracellular cAMP generation in cardiovascular tissues. This receptor blockade reduces peripheral vascular resistance and myocardial workload, resulting in lowered systemic blood pressure and vascular protection relevant to clinical investigations in hypertension, endothelial dysfunction, and diabetes mellitus.

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>).