Silodosin

Generic Name: Silodosin

Brand Names: Rapaflo, Silodyx, Urorec, Silodosin Recordati

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₂F_₃N_₃O_₄

CAS Number: 160970-54-7

Unique Ingredient Identifier: CUZ39LUY82

Background: Silodosin is a selective antagonist of alpha(α)-1 adrenergic receptors that binds to the α subtype with the highest affinity. α1-adrenergic receptors regulate smooth muscle tone in the bladder neck, prostate, and prostatic urethra: the α subtype accounts for approximately 75% of α1-adrenoceptors in the prostate.
...

Indication: Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension.

Associated Conditions: Benign Prostatic Hyperplasia (BPH)

Associated Therapies: -

Clinical Trials

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

Phase 4

Completed

Conditions: Nocturia
Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin
Other: Laboratory tests
Other: 3-days voiding diary
Other: 12 weeks

First Posted Date: 2014-04-08

Last Posted Date: 2017-03-10

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 135

Registration Number: NCT02106182

Locations: 🇰🇷
Bucheon St.Mary's Hospital, Bucheon, Gyeonggi-do, Korea, Republic of
🇰🇷
Hanyang University Hospital, Seoul, Korea, Republic of
🇰🇷
Soon Chun Hyang University Hospital, Seoul, Korea, Republic of

and more 3 locations

Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

Phase 3

Terminated

Conditions: Expulsive Medical Therapy
Kidney Stone

Interventions: Drug: Silodosin

First Posted Date: 2014-03-18

Last Posted Date: 2016-02-11

Lead Sponsor: Centre Hospitalier Departemental Vendee

Target Recruit Count: 8

Registration Number: NCT02090439

Locations: 🇫🇷
CH Loire Vendée Océan, Challans, France
🇫🇷
Centre hospitalier départemental Vendée, La Roche sur Yon, France

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin

First Posted Date: 2012-12-31

Last Posted Date: 2014-04-29

Lead Sponsor: RECORDATI GROUP

Target Recruit Count: 1036

Registration Number: NCT01757769

Locations: 🇮🇹
Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele, Milan, Italy

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Phase 3

Withdrawn

Conditions: Kidney Stones

Interventions: Procedure: Extra-corporeal shock wave lithotripsy
Drug: silodosin
Drug: Tamsulosin

First Posted Date: 2012-03-22

Last Posted Date: 2017-02-17

Lead Sponsor: Albert Einstein Healthcare Network

Registration Number: NCT01560091

Locations: 🇺🇸
Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, United States

A Dose-finding Study of Silodosin in Patients With Urinary Calculi

Phase 2

Completed

Conditions: Urinary Calculus

Interventions: Drug: placebo
Drug: silodosin

First Posted Date: 2012-02-27

Last Posted Date: 2013-10-30

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Target Recruit Count: 300

Registration Number: NCT01539265

Locations: 🇯🇵
Japan, Tokyo and Other Japanese City, Japan

Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones

Phase 4

Completed

Conditions: Ureteral Stone

Interventions: Drug: Placebo
Drug: Silodosin

First Posted Date: 2012-02-15

Last Posted Date: 2013-11-20

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 114

Registration Number: NCT01533389

Locations: 🇰🇷
Kangbuk Samsung Medical Center, Seoul, Korea, Republic of
🇰🇷
Eulji General Hospital, Seoul, Korea, Republic of
🇰🇷
NHIC Ilsan Hospital, Goyang-Si, Gyonggi-Do, Korea, Republic of

and more 2 locations

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Phase 4

Completed

Conditions: Benign Prostatic Hypertrophy

Interventions: Drug: Silodosin

First Posted Date: 2010-12-15

Last Posted Date: 2012-03-30

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 424

Registration Number: NCT01260129

Locations: 🇰🇷
The Catholic Univ., Bucheon ST.Mary's Hospital, Bucheon, Korea, Republic of
🇰🇷
Chonnam Univ. Hospital, Hwasun, Korea, Republic of
🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

and more 11 locations

Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin

First Posted Date: 2010-12-14

Last Posted Date: 2012-03-30

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 100

Registration Number: NCT01259531

Locations: 🇰🇷
Seoul national university hospital, Seoul, Korea, Republic of

Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder

Phase 4

Completed

Conditions: Neurogenic Bladder
Voiding Dysfunction

Interventions: Drug: silodosin

First Posted Date: 2010-10-26

Last Posted Date: 2012-10-05

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 95

Registration Number: NCT01228370

Locations: 🇰🇷
Daegu Catholic Univ. Medical Center, Daegu, Daegu City, Korea, Republic of
🇰🇷
Daegu Fatima Hospital, Daegu, Daegu City, Korea, Republic of
🇰🇷
Yeungnam Univ. Medical Center, Daegu, Daegu City, Korea, Republic of

and more 3 locations

A Comparative Study of KSO-0400 in BPH Patients With LUTS

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia (BPH)

Interventions: Drug: KSO-0400
Drug: Silodosin
Drug: Placebo

First Posted Date: 2010-10-18

Last Posted Date: 2011-07-04

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Target Recruit Count: 400

Registration Number: NCT01222650

Locations: 🇯🇵
Japan, Kanto region, Japan

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