Clinical Trials

The clinical evaluation of doxazosin encompasses several completed Phase 1, Phase 2, and Phase 4 trials sponsored by pharmaceutical companies such as Pfizer, alongside academic centers and public institutes including the University of Dundee and the National Institute on Drug Abuse. These studies evaluated diverse therapeutic indications, including hypertension, benign prostatic hyperplasia, pheochromocytoma, and allergic rhinitis. Additionally, early-phase research investigated the drug's effects on physiological and subjective responses associated with cocaine addiction.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01946035 Completed
Allergic Rhinitis
University of Dundee
2013-09 Phase 4
NCT01379898 Completed
Pheochromocytoma
University Medical Center Groningen|Radboud University Medical Center|UMC Utrecht|VU University of Amsterdam|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|Leiden University Medical Center|Erasmus Medical Center|Maastricht University Medical Center|St. Antonius Hospital|Medisch Spectrum Twente|Maxima Medical Center|Canisius-Wilhelmina Hospital|Onze Lieve Vrouwe Gasthuis|Atrium Medical Center|Isala
2011-12 Phase 4
NCT01062945 Completed
Cocaine Addiction|Cocaine Abuse|Cocaine Dependence|Substance Abuse
Baylor College of Medicine|National Institute on Drug Abuse (NIDA)
2010-01 Phase 1
NCT00646841 Completed
Hypertension
Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.|Pfizer
2003-02 Phase 4
NCT00645034 Completed
Benign Prostatic Hyperplasia
Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.|Pfizer
2002-11 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxazosin selectively antagonizes postsynaptic α1-adrenergic receptors, thereby blocking catecholamine-induced intracellular signaling pathways that drive vascular and non-vascular smooth muscle contraction. The resulting inhibition of smooth muscle tone leads to vasodilation and decreased bladder neck resistance, underlying its therapeutic application in clinical conditions such as hypertension, benign prostatic hyperplasia, and pheochromocytoma.

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>).

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