Clinical Trials

Several clinical trials evaluate the therapeutic application of quinapril hydrochloride across cardiovascular and metabolic indications, focusing primarily on essential hypertension alone or with comorbidities such as type 2 diabetes mellitus or postmenopausal hypertension. Sponsored by pharmaceutical companies including Pfizer and LaborMed Pharma S.A., this clinical portfolio encompasses completed Phase 4 post-marketing evaluations and non-interventional safety and efficacy studies. All trials have achieved completed recruitment status, establishing real-world safety, tolerability, and blood pressure control.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00930722 Completed
Hypertension
Pfizer
 2009-06 --
NCT00980187 Completed
Hypertension|Type 2 Diabetes Mellitus
LaborMed Pharma S.A.
 2008-03 Phase 4
NCT00147524 Completed
Menopause|Hypertension
Pfizer
 2003-10 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quinapril hydrochloride is a prodrug converted in vivo to quinaprilat, which selectively binds to and inhibits angiotensin-converting enzyme, thereby blocking the conversion of angiotensin I to the potent vasoconstrictor angiotensin II. This enzymatic blockade reduces systemic vasoconstriction and diminishes aldosterone secretion, promoting urinary sodium excretion and lowering arterial vascular resistance to reduce blood pressure in clinical conditions such as 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>).

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Note: Technical data last updated: Sep 1, 2026.