Diltiazem HCl Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A Phase 3 clinical trial sponsored by an academic medical center, Radboud University Medical Center, is evaluating Diltiazem HCl for cardiovascular indications. Currently active, not recruiting, the study assesses the drug's potential to achieve coronary microvascular improvement in patients with microvascular angina, coronary vasospasm, and microvascular ischemia of the myocardium.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04777045	Active not recruiting	Microvascular Angina\|Coronary Vasospasm\|Microvascular Ischemia of Myocardium	Radboud University Medical Center	2019-10-25	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diltiazem HCl functions as a benzothiazepine calcium channel antagonist that selectively targets membrane-bound calcium channels, thereby inhibiting extracellular calcium influx into myocardial and vascular smooth muscle cells. The resulting suppression of muscle cell contraction promotes systemic and coronary arterial vasodilation, offering key therapeutic efficacy in mitigating microvascular angina, coronary vasospasm, and microvascular myocardial ischemia.

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>).