Isosorbide dinitrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate isosorbide dinitrate across diverse indications, including tourniquet-induced hypertension during local anesthesia, hemodynamic parameters in Fontan patients, and medical management of late fetal death and cervical pregnancy. Sponsored by academic and clinical institutions such as Hospital da Luz Portugal, Children's Hospital Medical Center Cincinnati, and the National Institute of Perinatology in Mexico, these Phase 2, Phase 4, and non-applicable phase studies encompass both completed trials and those not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05954689	Not yet recruiting	Tourniquets\|Anesthesia Conduction\|Anesthetics Local\|Hypertension	Hospital da Luz Portugal	2023-07-10	Not Applicable
NCT04297241	Completed	Fontan	Children''s Hospital Medical Center Cincinnati	2019-12-12	Phase 2
NCT02488642	Completed	Cervical Pregnancy\|Maternal Care for Late Fetal Death	National Institute of Perinatology\|National Council of Science and Technology Mexico	2008-05	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isosorbide dinitrate undergoes biotransformation to generate nitric oxide, which activates guanylate cyclase to elevate intracellular cyclic guanosine monophosphate levels. This cascade induces smooth muscle relaxation and systemic vasodilation, thereby reducing vascular resistance and modulating blood pressure in clinical conditions such as tourniquet-induced hypertension and Fontan physiology.

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>).