Trandolapril Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated trandolapril across healthy subjects and patients with hypertension, with all registered studies having reached completed status. These trials comprise Phase 1 pharmacokinetic and bioequivalence assessments in healthy volunteers alongside Phase 4 post-marketing evaluations of blood pressure response and metabolic effects in hypertensive populations. Research sponsors encompass academic, governmental, and commercial entities, including the University of Florida, the National Heart, Lung, and Blood Institute, Teva Pharmaceuticals USA, and Abbott.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00887510	Completed	Hypertension	University of Florida\|National Heart Lung and Blood Institute (NHLBI)	2007-05	Phase 4
NCT00840073	Completed	Healthy	Teva Pharmaceuticals USA	2004-10	Phase 1
NCT00840632	Completed	Healthy	Teva Pharmaceuticals USA	2004-10	Phase 1
NCT00233532	Completed	Hypertension	Abbott	2004-03	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trandolapril is a prodrug that undergoes hepatic hydrolysis to its active metabolite trandolaprilat, which competitively inhibits angiotensin-converting enzyme to prevent the conversion of angiotensin I to angiotensin II. This inhibition blocks downstream angiotensin II-mediated vasoconstriction and aldosterone release, thereby reducing peripheral vascular resistance and lowering blood pressure in the clinical management of hypertension.

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>).