Olmesartan Medoxomil Clinical Trials

Size	Price	Qty
10mg	USD 110

Clinical Trials

Multiple completed clinical trials sponsored by Daiichi Sankyo and Sankyo Pharma GmbH have evaluated the therapeutic profile of Olmesartan Medoxomil. These include a Phase 4 clinical trial investigating the comparative pharmacodynamic effects of single high doses in healthy volunteers, as well as a Phase 3 clinical trial assessing the impact of dosing regimens on proteinuria, renal function, and inflammatory markers in patients with type 2 diabetes mellitus, diabetic nephropathy, and renal disease. These completed studies demonstrate a focus on broad hemodynamics and targeted renal protection.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00185055	Completed	Healthy	Daiichi Sankyo	2004-11	Phase 4
NCT00362960	Completed	Type 2 Diabetes Mellitus\|Diabetic Nephropathy\|Proteinuria\|Renal Disease	Sankyo Pharma Gmbh\|Daiichi Sankyo	2003-05	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olmesartan medoxomil is bioactivated via hydrolysis to olmesartan, which selectively binds to and antagonizes the angiotensin II type 1 (AT1) receptor, blocking angiotensin II-mediated vasoconstriction and aldosterone secretion in vascular tissue. This pathway inhibition induces systemic vasodilation and lowers peripheral resistance, providing clinical efficacy in reducing blood pressure and offering renal protection against proteinuria in patients with diabetic nephropathy.

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>).