Cilnidipine Clinical Trials

Size	Price	Qty
50mg	USD 109
200mg	USD 297

Clinical Trials

Cilnidipine has been evaluated in several clinical trials spanning Phase 1 through Phase 4, focusing on hypertension, stroke, metabolic syndrome X, autosomal dominant polycystic kidney disease, and pharmacokinetic evaluations in healthy volunteers. Key late-phase investigations assess therapeutic efficacy, cerebral blood flow, and combination drug regimens, sponsored by pharmaceutical companies such as IlDong and Boryung alongside institutions like Kyorin University and the Ministry of Health, Labour and Welfare of Japan. These trials encompass both completed and unknown recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02145104	COMPLETED	Hypertension	IlDong Pharmaceutical Co Ltd	2014-06-17	PHASE3
NCT02343250	COMPLETED	Hypertension	IlDong Pharmaceutical Co Ltd	2015-03	PHASE1
NCT02088008	UNKNOWN	Healthy Volunteers	IlDong Pharmaceutical Co Ltd	2014-05	PHASE1
NCT01838967	COMPLETED	Healthy	IlDong Pharmaceutical Co Ltd	2013-04	PHASE1
NCT00890279	UNKNOWN	Kidney, Polycystic, Autosomal Dominant	Ministry of Health, Labour and Welfare, Japan	2009-07	PHASE2
NCT00325637	COMPLETED	Hypertension; Stroke	Boryung Pharmaceutical Co., Ltd	2005-01	PHASE3
NCT00325936	COMPLETED	Hypertension; Metabolic Syndrome X	Boryung Pharmaceutical Co., Ltd	2005-07	PHASE4
NCT00541853	UNKNOWN	Kidney, Polycystic, Autosomal Dominant	Kyorin University	2007-12	PHASE4

(data from https://clinicaltrials.gov, updated on 2018-06-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilnidipine dual-binds to L-type voltage-gated calcium channels in vascular smooth muscle cells and N-type calcium channels in sympathetic nerve terminals, which blocks extracellular calcium influx and suppresses norepinephrine release from sympathetic nerves. This dual channel inhibition causes arterial vasodilation and dampens sympathetic nervous system drive, thereby reducing systemic arterial pressure for the clinical management of hypertension, stroke, and related cardiovascular conditions.

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>).