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Last Updated: May 28, 2020

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CLINICAL TRIALS PROFILE FOR TAMSULOSIN HYDROCHLORIDE

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505(b)(2) Clinical Trials for Tamsulosin 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
OTC NCT01726270 An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms Completed Boehringer Ingelheim Phase 2 2012-11-01 Multicenter trial conducted in Pharmacy retail centers
OTC NCT02573311 Actual Use Study of Tamsulosin in Men Completed Boehringer Ingelheim Phase 3 2015-09-01 An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tamsulosin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090103 Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment Completed GlaxoSmithKline Phase 3 2003-11-01 This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
NCT00147654 Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction Completed Pfizer Phase 4 2004-11-01 The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
NCT00151567 Evaluation of Tamsulosin in the Treatment of Ureteral Stones Completed Ministry of Health, France Phase 3 2002-02-01 Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
NCT00151567 Evaluation of Tamsulosin in the Treatment of Ureteral Stones Completed Yamanouchi Phase 3 2002-02-01 Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tamsulosin Hydrochloride

Condition Name

Condition Name for Tamsulosin Hydrochloride
Intervention Trials
Benign Prostatic Hyperplasia 30
Prostatic Hyperplasia 29
Lower Urinary Tract Symptoms 13
Urinary Retention 10
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Condition MeSH

Condition MeSH for Tamsulosin Hydrochloride
Intervention Trials
Prostatic Hyperplasia 71
Hyperplasia 69
Lower Urinary Tract Symptoms 25
Urinary Retention 17
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Clinical Trial Locations for Tamsulosin Hydrochloride

Trials by Country

Trials by Country for Tamsulosin Hydrochloride
Location Trials
United States 197
Germany 41
Korea, Republic of 33
Italy 27
United Kingdom 24
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Trials by US State

Trials by US State for Tamsulosin Hydrochloride
Location Trials
New York 11
California 11
Texas 10
Florida 9
Alabama 9
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Clinical Trial Progress for Tamsulosin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tamsulosin Hydrochloride
Clinical Trial Phase Trials
Phase 4 42
Phase 3 37
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Tamsulosin Hydrochloride
Clinical Trial Phase Trials
Completed 93
Recruiting 27
Unknown status 20
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Clinical Trial Sponsors for Tamsulosin Hydrochloride

Sponsor Name

Sponsor Name for Tamsulosin Hydrochloride
Sponsor Trials
Boehringer Ingelheim 20
GlaxoSmithKline 20
Astellas Pharma Inc 13
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Sponsor Type

Sponsor Type for Tamsulosin Hydrochloride
Sponsor Trials
Industry 103
Other 91
U.S. Fed 2
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