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)
Mechanism and Biochemical Profile
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>).