CLINICAL TRIALS PROFILE FOR ALFUZOSIN HYDROCHLORIDE

505(b)(2) Clinical Trials for ALFUZOSIN HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00280605 ↗	ALF-ONE : ALFuzosin ONcE Daily	Completed	Sanofi	Phase 4	2005-08-01	The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
New Formulation	NCT00542165 ↗	Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy	Completed	Sanofi	Phase 4	2004-03-01	To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy

All Clinical Trials for ALFUZOSIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00029822 ↗	Clinical Trial in Males With BPH (Enlarged Prostate)	Completed	Sanofi	Phase 3	2001-05-01	A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. - Free study-related medical care provided.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	Diagnostic Ultrasound	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	Medtronic	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	Merck Sharp & Dohme Corp.	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	Sanofi-Synthelabo	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	Urologix	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗	Minimally Invasive Surgical Therapy for BPH	Terminated	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2004-04-01	The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

Clinical Trial Conditions for ALFUZOSIN HYDROCHLORIDE

Condition Name

Condition Name for ALFUZOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	9
Benign Prostatic Hyperplasia	9
Healthy	3
Urinary Retention	3

Condition MeSH

Condition MeSH for ALFUZOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	20
Hyperplasia	19
Lower Urinary Tract Symptoms	10
Urinary Retention	5

Clinical Trial Locations for ALFUZOSIN HYDROCHLORIDE

Trials by Country

Trials by Country for ALFUZOSIN HYDROCHLORIDE
Location	Trials
United States	46
Canada	6
Korea, Republic of	6
India	4
Israel	3

Trials by US State

Trials by US State for ALFUZOSIN HYDROCHLORIDE
Location	Trials
Massachusetts	3
Maryland	3
Illinois	3
California	3
Minnesota	3

Clinical Trial Progress for ALFUZOSIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ALFUZOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	17
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ALFUZOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	29
Unknown status	6
Terminated	5

Clinical Trial Sponsors for ALFUZOSIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for ALFUZOSIN HYDROCHLORIDE
Sponsor	Trials
Sanofi	25
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	4
Samsung Medical Center	4

Sponsor Type

Sponsor Type for ALFUZOSIN HYDROCHLORIDE
Sponsor	Trials
Industry	37
Other	24
NIH	5