Amlodipine maleate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial evaluates amlodipine-based interventions for primary hypertension to assess the comparative effectiveness of amlodipine formulations in controlling elevated blood pressure. Listed with an unassigned phase and an unknown recruitment status, the study is supported by medical institutions, government organizations, and industry partners, including Peking University First Hospital, the Ministry of Science and Technology of the People's Republic of China, Southern Medical University, and CSPC Ouyi Pharmaceutical Co. Ltd.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
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 Amlodipine maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amlodipine maleate selectively binds to L-type voltage-gated calcium channels in vascular smooth muscle cells, inhibiting the transmembrane influx of extracellular calcium ions. Consequently, decreased intracellular calcium levels suppress muscle contraction to induce peripheral vasodilation and reduce systemic vascular resistance, effectively lowering blood pressure in clinical conditions such as 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>).