Midodrine Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic utility of midodrine across cardiovascular and hepatic indications, including heart failure with reduced ejection fraction accompanied by hypotension, paracentesis-induced circulatory dysfunction, chronic liver disease, and septic shock. Sponsored by academic institutions such as the Ottawa Heart Institute Research Corporation, the Asian Institute of Gastroenterology, the Institute of Liver and Biliary Sciences, and Ain Shams University, these studies encompass Phase 2/3, Phase 3, Phase 4, and unassigned phase designs. With recruitment statuses spanning from not yet recruiting to completed, these trials reflect ongoing clinical interest in optimizing systemic hemodynamics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06405555	Not yet recruiting	Heart Failure With Reduced Ejection Fraction\|Hypotension\|LV Dysfunction	Ottawa Heart Institute Research Corporation	2024-08-01	Phase 2\|Phase 3
NCT05240391	Completed	Paracentesis-Induced Circulatory Dysfunction	Asian Institute of Gastroenterology India	2021-02-20	Phase 3
NCT04455464	Completed	Chronic Liver Disease	Institute of Liver and Biliary Sciences India	2020-07-11	Not Applicable
NCT03911817	Completed	Septic Shock	Ain Shams University	2017-11-15	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Midodrine acts as a prodrug for the selective alpha-1 adrenergic receptor agonist desglymidodrine, which binds peripheral vascular alpha-1 receptors to trigger Gq-protein-mediated calcium influx and induce vascular smooth muscle contraction. This vasoconstrictive action increases systemic vascular resistance and venous return, mitigating severe hypotension and circulatory failure across clinical indications such as septic shock, paracentesis-induced circulatory dysfunction, and heart failure with reduced ejection fraction.

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>).