Disopyramide Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate the therapeutic application of disopyramide in cardiovascular conditions, primarily cardiac arrhythmias, atrial fibrillation, and hypertrophic cardiomyopathy. Ranging in recruitment status from completed to unknown, these Phase 3 studies and clinical assessments encompass rhythm management in the AFFIRM trial, catheter ablation comparisons, quality-of-life evaluations, and echocardiographic efficacy analyses. Sponsorship is provided by medical centers and federal institutes, including the National Heart, Lung, and Blood Institute, Rabin Medical Center, and Uppsala University Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02294955	UNKNOWN	Atrial Fibrillation; Quality of Life	Uppsala University Hospital	2008-05
NCT02917395	UNKNOWN	Cardiomyopathy	Rabin Medical Center	2016-11
NCT00000556	COMPLETED	Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases	National Heart, Lung, and Blood Institute (NHLBI)	1995-03	PHASE3

(data from https://clinicaltrials.gov, updated on 2017-05-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Disopyramide functions by binding directly to cardiac voltage-gated sodium channels to inhibit inward sodium current, thereby depressing phase 0 of the cardiac action potential and slowing AV nodal conduction velocity. This cellular electrophysiological inhibition decreases myocardial excitability and extends the effective refractory period, providing therapeutic clinical efficacy in controlling cardiac arrhythmias, atrial fibrillation, and symptomatic obstructive cardiomyopathy.

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>).