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Last Updated: June 3, 2020

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CLINICAL TRIALS PROFILE FOR ALFUZOSIN HYDROCHLORIDE

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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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Alfuzosin Hydrochloride
Intervention Trials
Prostatic Hyperplasia 20
Hyperplasia 19
Lower Urinary Tract Symptoms 10
Urinary Retention 5
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Clinical Trial Locations for Alfuzosin Hydrochloride

Trials by Country

Trials by Country for Alfuzosin Hydrochloride
Location Trials
United States 44
Korea, Republic of 6
Canada 6
India 4
Israel 3
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Trials by US State

Trials by US State for Alfuzosin Hydrochloride
Location Trials
Maryland 3
California 3
Minnesota 3
Pennsylvania 3
New York 3
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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
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Clinical Trial Status

Clinical Trial Status for Alfuzosin Hydrochloride
Clinical Trial Phase Trials
Completed 27
Unknown status 6
Terminated 5
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Clinical Trial Sponsors for Alfuzosin Hydrochloride

Sponsor Name

Sponsor Name for Alfuzosin Hydrochloride
Sponsor Trials
Sanofi 25
Samsung Medical Center 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for Alfuzosin Hydrochloride
Sponsor Trials
Industry 35
Other 21
NIH 2
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