Levamlodipine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate levamlodipine primarily for hypertension and primary hypertension, encompassing Phase 1 pharmacokinetic and safety assessments alongside comparative effectiveness research. Sponsored by academic institutions such as Peking University First Hospital and pharmaceutical companies including Chong Kun Dang and CSPC Ouyi, these studies include completed Phase 1 evaluations of fixed-dose combinations as well as comparative trials with unknown recruitment status. Collectively, these data support the therapeutic characterization of levamlodipine in cardiovascular medicine.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02358824	Completed	Hypertension	Chong Kun Dang Pharmaceutical	2015-02	Phase 1
NCT02250833	Completed	Hypertension	Chong Kun Dang Pharmaceutical	2014-09	Phase 1
NCT01844570	Unknown status	Primary Hypertension	Peking University First Hospital\|Ministry of Science and Technology of the People´s Republic of China\|Southern Medical University China\|CSPC Ouyi Pharmaceutical Co. Ltd.	2013-02	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a dihydropyridine calcium channel blocker, levamlodipine selectively binds to and inhibits L-type voltage-gated calcium channels in vascular smooth muscle cells, thereby preventing calcium influx and downstream cellular contraction. This blockade promotes peripheral arterial vasodilation and reduces systemic vascular resistance, providing the pharmacological rationale for lowering blood pressure in clinical settings such as hypertension and primary hypertension.

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>).