Midodrine hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

Multiple clinical trials evaluate midodrine hydrochloride across various cardiovascular and systemic conditions, including heart failure with reduced ejection fraction accompanied by hypotension and left ventricular dysfunction, paracentesis-induced circulatory dysfunction, advanced chronic liver disease, and septic shock. Sponsored by diverse academic and medical institutions, these studies span non-phase pilot evaluations to late-stage Phase 2/3, Phase 3, and Phase 4 trials. Recruitment statuses for these investigations currently range from completed to not yet recruiting.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Midodrine hydrochloride acts as a prodrug that is converted to its active metabolite, desglymidodrine, which selectively binds to and activates peripheral alpha-1 adrenergic receptors to trigger vascular smooth muscle contraction. This vasoconstrictive response increases systemic vascular resistance and elevates arterial blood pressure, offering therapeutic relevance in managing conditions such as septic shock, chronic liver disease complications, and hypotension associated with heart failure.

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>).