Doxazosin

also known as Cardura (Doxazosin Mesylate) · Cardura XL · Cardura · Doxaben XL · Doxazosin GITS · doxazosin XL

Developed for: hypertensive disorder · post-traumatic stress disorder · alcohol-related disorders · benign prostatic hyperplasia · cocaine dependence · essential hypertension · alcohol dependence · allergic rhinitis
+11 more
· benign essential hypertension · coronary microvascular disorder · diabetic kidney disease · paraganglioma · pheochromocytoma · prostate disorder · substance-related disorder · urinary tract obstruction · non-familial dilated cardiomyopathy · resistant hypertension · urolithiasis
Investigated by: Baylor College of Medicine · National Institute on Drug Abuse (NIDA) · Brown University · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Northern California Institute of Research and Education
+32 more
· San Francisco Veterans Affairs Medical Center · United States Department of Defense · VA Office of Research and Development · Viatris Inc. · Boehringer Ingelheim · Buddhist Tzu Chi General Hospital · Charite University, Berlin, Germany · Danish Cardiovascular Research Academy · Danish Heart Foundation · Eisai Inc. · George Washington University · German Federal Ministry of Education and Research · Hospital Authority, Hong Kong · Instituto de Cardiologia do Rio Grande do Sul · Japan Heart Foundation · Medical University of South Carolina · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Novartis · Samsung Medical Center · St George's, University of London · The University of Texas Health Science Center, Houston · University Hospital, Basel, Switzerland · University of Aarhus · University of Arkansas · University of California, Los Angeles · University of Campania Luigi Vanvitelli · University of Dundee · University of Minnesota · University of Wisconsin, Madison · VIVUS LLC · Yale University · Yokohama City University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	CARDURA	—	1990-11-02	fda.gov ↗

Trials 33

today

US approved 1990

NCT05360953 · Ph 2 NCT03398252 · Ph 1 NCT04371757 · not/applicable NCT04135846 · Ph 2 NCT03339258 · Ph 2 NCT03176693 · Ph 3 NCT02989493 · Ph 2 NCT02500602 · Ph 2 NCT01953432 · Ph 2 NCT01959022 · Ph 4 NCT01946035 · Ph 4 NCT01730846 · Ph 2 NCT01661621 · Ph 4 NCT01437046 · Ph 0 NCT01386177 · Ph 1 NCT01371851 · Ph 1/2 NCT01145183 · Ph 2 NCT01100021 · Ph 1 NCT00880997 · Ph 1 NCT00730418 · not/applicable NCT00424801 · not/applicable NCT02266537 · Ph 1 NCT00563485 · not/applicable NCT00535925 · Ph 4 NCT00130156 · Ph 4 NCT00295555 · Ph 4 NCT00648323 · Ph 4 NCT00285519 · Ph 4 NCT00141596 · not/applicable NCT00646841 · Ph 4 NCT00021814 · Ph 3 NCT00000542 · Ph 3 NCT00000522 · Ph 2

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT01437046	Nov 2011 → Aug 2013	alcohol dependence, anxiety	Brown University	Completed	No outcome recorded
Phase 15 trials
Phase 1	NCT03398252	May 2022 → Oct 2023	alcohol-related disorders	The University of Texas Health Science Center, Houston	Withdrawn	No outcome recorded Stop: Business
Phase 1	NCT01386177	Jul 2011 → Jan 2012	amphetamine abuse, mood disorder	University Hospital, Basel, Switzerland	Completed	No outcome recorded
Phase 1	NCT01100021	Feb → Mar 2010	erectile dysfunction	VIVUS LLC	Completed	No outcome recorded
Phase 1	NCT00880997	Sep 2009 → Apr 2011	cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT02266537	Nov 2005 → Feb 2006	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1/21 trial · 1 missed
Phase 1/2	NCT01371851	Jun 2011 → May 2014	substance-related disorder	University of Arkansas	Completed	Missed primary
Phase 29 trials · 3 missed
Phase 2	NCT05360953	Jun 2022 → Aug 2025	post-traumatic stress disorder	Charite University, Berlin, Germany	Suspended	No outcome recorded Stop: Enrollment
Phase 2	NCT04135846	Aug 2019 → Dec 2026 expected	alcohol-related disorders	Brown University	Active not recruiting	Missed primary
Phase 2	NCT03339258	Apr 2018 → Jun 2024	post-traumatic stress disorder	San Francisco Veterans Affairs Medical Center	Unknown	Missed primary
Phase 2	NCT02989493	Apr 2017 → Mar 2020	alcohol dependence	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 2	NCT02500602	Jun 2016 → Dec 2019	alcohol-related disorders, post-traumatic stress disorder	VA Office of Research and Development	Completed	Missed primary
Phase 2	NCT01953432	Apr 2014 → Sep 2017	cocaine dependence	VA Office of Research and Development	Completed	No outcome recorded
Phase 2	NCT01730846	Feb 2013 → Nov 2016	—	Yale University	Completed	No outcome recorded
Phase 2	NCT01145183	Mar 2010 → Sep 2015	cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 2	NCT00000522	Aug 1985 → May 1994	heart disorder, hypertensive disorder	University of Minnesota	Completed	No outcome recorded
Phase 33 trials · 1 met primary · 1 missed
Phase 3	NCT03176693	May 2017 → Jan 2020	paraganglioma, pheochromocytoma	University of California, Los Angeles	Completed	No outcome recorded
Phase 3	NCT00021814	Dec 1995 → Nov 2001	benign prostatic hyperplasia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	Met primary
Phase 3	NCT00000542	Aug 1993 → Mar 2002	coronary artery disorder, diabetes mellitus, heart failure, hyperlipidemia +3	National Heart, Lung, and Blood Institute (NHLBI)	Completed	Missed primary
Phase 49 trials
Phase 4	NCT01959022	Oct 2013 → Jun 2016	post-traumatic stress disorder	San Francisco Veterans Affairs Medical Center	Completed	No outcome recorded
Phase 4	NCT01946035	Sep 2013 → Jun 2015	allergic rhinitis	University of Dundee	Completed	No outcome recorded
Phase 4	NCT01661621	Aug 2012 → Aug 2013	urinary tract obstruction	Buddhist Tzu Chi General Hospital	Completed	No outcome recorded
Phase 4	NCT00535925	Oct 2005 → Dec 2011	diabetic kidney disease	University of Campania Luigi Vanvitelli	Completed	No outcome recorded
Phase 4	NCT00130156	Oct 2005 → Sep 2008	benign essential hypertension	Eisai Inc.	Completed	No outcome recorded
Phase 4	NCT00295555	Jan 2004 → Apr 2007	diabetes mellitus, essential hypertension, kidney failure	Yokohama City University Medical Center	Completed	No outcome recorded
Phase 4	NCT00648323	Nov 2003 → Jan 2005	prostate disorder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00285519	Aug 2003 → Aug 2005	hypertensive disorder	Japan Heart Foundation	Completed	No outcome recorded
Phase 4	NCT00646841	Feb 2003 → Feb 2004	essential hypertension	Viatris Inc.	Completed	No outcome recorded
Phase not applicable5 trials
—	NCT04371757	Apr → Dec 2020	autonomic nervous system disorder, hypertensive disorder	Instituto de Cardiologia do Rio Grande do Sul	Unknown	No outcome recorded
—	NCT00730418	Jan 2007 → Mar 2010	benign prostatic hyperplasia	Samsung Medical Center	Completed	No outcome recorded
—	NCT00424801	Jan 2007 → Dec 2008	coronary microvascular disorder, essential hypertension	University of Aarhus	Terminated	No outcome recorded
—	NCT00563485	Oct 2005 → Nov 2006	benign prostatic hyperplasia	Hospital Authority, Hong Kong	Terminated	No outcome recorded
—	NCT00141596	Jul 2003 → Oct 2006	hypertensive disorder	St George's, University of London	Terminated	No outcome recorded Stop: Enrollment
Comparator or background therapy17 trials
Phase 1	NCT02538744 Comparator	Aug 2015 → Aug 2018	cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT02308202 Comparator	Jan 2012 → Jun 2014	post-traumatic stress disorder	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT02785393 Comparator	Mar 2011 → Mar 2016	substance-related disorder	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT01062945 Comparator	Jan 2010 → Jan 2011	cocaine abuse, cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 2	NCT01678313 Background	Aug 2012 → Aug 2013	benign prostatic hyperplasia	Buddhist Tzu Chi General Hospital	Completed	No outcome recorded
Phase 2/3	NCT02563405 Comparator	Sep 2015 → Oct 2017	hypertensive disorder	First Affiliated Hospital of Harbin Medical University	Unknown	No outcome recorded
Phase 3	NCT00713739 Comparator	Jan 2008 → Dec 2010	urolithiasis	United States Naval Medical Center, San Diego	Unknown	No outcome recorded
Phase 4	NCT01379898 Comparator	Dec 2011 → Jan 2018	pheochromocytoma	University Medical Center Groningen	Completed	No outcome recorded
Phase 4	NCT02901977 Comparator	Mar 2011 → Feb 2015	hypertensive disorder	Karolinska Institutet	Completed	No outcome recorded
Phase 4	NCT00922506 Background	May 2009 → May 2014	benign prostatic hyperplasia, overactive bladder	Samsung Medical Center	Completed	No outcome recorded
Phase 4	NCT02369081 Comparator	May 2009 → Jul 2015	resistant hypertension	University of Cambridge	Unknown	No outcome recorded
Phase 4	NCT00687388 Comparator	May 2008 → Mar 2012	benign prostatic hyperplasia	Samsung Medical Center	Withdrawn	No outcome recorded
Phase 4	NCT00661895 Background	Aug 2005 → Aug 2009	hypertensive disorder	Creighton University	Completed	No outcome recorded
Phase 4	NCT01798992 Comparator	Sep 2000 → Mar 2009	non-familial dilated cardiomyopathy	University of Colorado, Denver	Completed	No outcome recorded
Phase 4	NCT00295542 Comparator	Mar 2000 → Apr 2009	hypertensive disorder	University of Vigo	Completed	No outcome recorded
—	NCT05094947 Background	Aug 2021 → Mar 2022	benign prostatic hyperplasia	Moscow State University of Medicine and Dentistry	Unknown	No outcome recorded
—	NCT00684489 Comparator	Sep 2003 → Mar 2005	essential hypertension	Medical University of South Carolina	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2000-10-22	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Received Final Approval for Doxazosin Mesylate tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the U.S. FDA final approval to manufacture and market Doxazosin Mesylate 1, 2, 4 and 8 mg Tablets.

All press releases naming this drug 2 releases

Date	Issuer	Release
2018-05-01	Upsher-Smith Laboratories	Upsher-Smith Launches Doxazosin Tablets, USP upsher-smith.com ↗
2000-10-22	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Received Final Approval for Doxazosin Mesylate tevapharm.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

Field	Value	Cited text
Known as	Doxazosin	“Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)” NCT00687388 ↗ 50 “Doxazosin produced clinically significant decreases in standing and supine blood pressures over a period of 1 year.” PMID 2884855 ↗ May 1987 “nisoldipine, doxazosin, prazosin, terazosin, clonidine” NCT00684489 ↗ “tamsulosin, alfuzosin, doxazosin, silodosin” NCT05094947 ↗ “doxazosin GITS (Cardura XL) 4 mg b.d.” NCT00141596 ↗ “Doxazosin” NCT04371757 ↗ NCT00000522 ↗ NCT03398252 ↗ NCT01371851 ↗ NCT01437046 ↗ NCT00922506 ↗ Show 40 more sources
Known as	Cardura	“oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together” NCT00021814 ↗
Known as	Cardura (Doxazosin Mesylate)	“Cardura (Doxazosin Mesylate)” NCT00880997 ↗ 2 “Cardura (Doxazosin Mesylate)” NCT01953432 ↗ “Cardura (Doxazosin Mesylate)” NCT01145183 ↗
Known as	Cardura XL	“doxazosin GITS (Cardura XL) 4 mg b.d.” NCT00141596 ↗ 1 “Doxazosin GITS (Cardura XL)” NCT00563485 ↗
Known as	Doxaben XL	“Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks.” NCT00130156 ↗
Known as	Doxazosin GITS	“Doxazosin GITS (Cardura XL)” NCT00563485 ↗
Known as	doxazosin XL	“The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.” NCT02308202 ↗
Action	Inhibit	“noradrenergic α(1) receptor antagonist doxazosin” PMID 22319592 ↗ Feb 2012
Route	Oral	“The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together” NCT00021814 ↗