Page last updated: 2024-12-07

tamsulosin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID129211
CHEMBL ID836
CHEBI ID9398
SCHEMBL ID34378
MeSH IDM0234193

Synonyms (86)

Synonym
BIDD:GT0261
AB01275521-01
(-)-ym617
gtpl488
5-{(2r)-2-[(2-{[2-(ethyloxy)phenyl]oxy}ethyl)amino]propyl}-2-(methyloxy)benzenesulfonamide
tamsulosinum [inn-latin]
benzenesulfonamide, 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxy-, (r)-
tamsulosina [inn-spanish]
tamsulosine [inn-french]
c20h28n2o5s
tamsulosin [inn:ban]
C07124
106133-20-4
tamsulosin ,
(-)-tamsulosin
DB00706
(r)-(-)-tamsulosin
(r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
flomax (tn)
amsulosin
NCGC00167442-01
5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl]-2-methoxybenzenesulfonamide
tamsulosine
tamsulosinum
CHEBI:9398 ,
tamsulosina
HMS2090P15
tamsulon
CHEMBL836 ,
hgp-0412
hip-1402
hip1402
D08560
tamsulosin (inn)
tamsulon (tn)
bdbm50060964
5-[2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxy-benzenesulfonamide
STK626950
5-[(2r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide
5-[(2r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxy-benzenesulfonamide
A801388
A835382
AKOS005266643
NCGC00167442-02
5-((2r)-2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxy-benzenesulfonamide
unii-g3p28oml5i
g3p28oml5i ,
flowmax
hsdb 7744
contiflo od
S1435
tamsulosin [hsdb]
(-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
tamsulosin [vandf]
tamsulosin [inn]
tamsulosin [mi]
tamsulosin [who-dd]
HY-B0661
SCHEMBL34378
DRHKJLXJIQTDTD-OAHLLOKOSA-N
5-[(2r)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzene-sulfonamide
smr004703489
MLS006011810
Q-101875
DTXSID3023631 ,
5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl]-2-methoxybenzene-1-sulfonamide
sr-05000001519
SR-05000001519-1
(r)-5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy-benzenesulfonamide
(r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)-propyl)-2-methoxybenzenesulfonamide
Q418480
F15143
(r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzenesulfonamide
HMS3884M15
CCG-268745
AS-82157
EN300-7417041
jgx ,
tamsulosine (inn-french)
tamsulosina (inn-spanish)
g04ca02
ym-12617-2
(r)-5-
dtxcid803631
tamsulosinum (inn-latin)
5-((2r)-2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide

Research Excerpts

Overview

Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. The drug well known by urologist that have a safety profile probed with the years.

ExcerptReferenceRelevance
"Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate."( Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study pro
Bieri, M; Bieri, U; Graf, N; Hefermehl, LJ; Nocito, A; Slieker, J; Soppe, S; Tedaldi, R; Teufelberger, G, 2021
)
1.56
"The tamsulosin is a drug well known by urologist that have a safety profile probed with the years. "( Physiopathology of the Priapism Secondary to Tamsulosin: Clinical Cases of Our Hospital and Literature Review.
Campos Hernández, JP; Gómez Gómez, E; Mellado Castillero, A; Prieto Castro, R, 2022
)
1.54
"Tamsulosin is a therapeutic drug of alpha-adrenergic antagonists. "( The effect of tamsulosin in postoperative urinary retention: a meta-analysis of randomized controlled trials.
Gao, B; Wang, Y; Wang, Z; Zhang, D, 2023
)
2.71
"Tamsulosin is an alpha-1 adrenergic receptor blocker used to treat benign prostatic hyperplasia."( A first case of fixed drug eruption due to Tamsulosin.
Ahmadi, A; Jahani Amiri, K; Mofarrah, R; Montazer, F; Nouripour, B, 2020
)
1.54
"Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms."( Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial.
Carchman, EH; Howington, B; Kennedy, GD; Leverson, G; Papageorge, CM, 2021
)
1.71
"Tamsulosin is an antagonist of a subtype-specific alpha-1A- and alpha-1D-adrenoceptor (AR) that is expressed in the prostate gland, urethra, and bladder. "( Intraoperative Floppy Iris Syndrome Induced by Tamsulosin: The Risk and Preventive Strategies.
Aalam, W; Al Haleem, ENA; Banji, D; Tobaiqy, M,
)
1.83
"Tamsulosin is a selective α1-AR antagonist."( Tamsulosin attenuates high glucose- induced injury in glomerular endothelial cells.
Hu, W; Sun, C; Sun, L; Zhang, L; Zhou, S, 2021
)
2.79
"Tamsulosin is an alpha blocker that works by relaxing bladder neck muscles."( Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery.
Cataldo, T; Curran, T; Nagle, D; Poylin, V, 2015
)
1.46
"Tamsulosin is an alpha(1)-adrenergic antagonist known to be linked with intraoperative floppy-iris syndrome (IFIS), which is characterized by iris atonicity and a propensity toward progressive intraoperative pupil constriction and iris prolapse. "( Management of intraoperative floppy-iris syndrome-associated iris prolapse using a single iris retractor.
Alexander, P; Tint, NL; Yeung, AM, 2009
)
1.8
"Tamsulosin is a safe and effective drug that enhances spontaneous passage of distal ureteral stones sized 10 mm or smaller."( Efficacy of tamsulosin in the management of lower ureteral stones: a randomized double-blind placebo-controlled study of 100 patients.
Al-Ansari, A; Al-Naimi, A; Alobaidy, A; Assadiq, K; Azmi, MD; Shokeir, AA, 2010
)
2.18
"Tamsulosin is an alpha(1)-adrenoceptor antagonist used for the treatment of lower urinary tract symptoms that are suggestive of benign prostatic hyperplasia. "( Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral controlled absorption system formulations.
de la Rosette, JJ; Franco-Salinas, G; Michel, MC, 2010
)
2.07
"Tamsulosin is a safe and effective therapy for renal and ureteral stones after SWL. "( Tamsulosin as adjunctive treatment after shockwave lithotripsy in patients with upper urinary tract stones: a systematic review and meta-analysis.
Liu, LR; Wei, Q; Yuan, HC; Zheng, S, 2010
)
3.25
"Tamsulosin is an α-adrenoceptor blocker that is relatively selective for the α(1A)-adrenoceptor subtype within the prostatic smooth muscles."( Dutasteride/tamsulosin fixed-dose combination for the treatment of benign prostatic enlargement.
Hashim, H; Ismail, M, 2012
)
1.48
"Tamsulosin is a safe and effective medical expulsive therapy choice for ureteral stones. "( Tamsulosin for ureteral stones: a systematic review and meta-analysis of a randomized controlled trial.
Ding, H; Dong, Z; Lu, Z; Ma, B; Wang, H; Wang, Z, 2012
)
3.26
"Tamsulosin is a uroselective alpha1A/alpha1D adrenergic receptor antagonist."( Efficacy and safety of tamsulosin in the treatment of benign prostatic hyperplasia.
Bijelic, R; Milicevic, S, 2012
)
1.41
"Tamsulosin is an alpha-1 adrenoceptor antagonist applied in treating lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). "( Efficacy and safety of orally disintegrating tamsulosin tablets in Taiwanese patients with benign prostatic hyperplasia.
Lee, LM; Lin, KH; Lin, YW; Wen, YC, 2012
)
2.08
"Tamsulosin appears to be a suitable compound for studying the characteristics of drug binding to human AGP F1/S variants under clinical conditions."( Selective binding of tamsulosin to genetic variants of human alpha1-acid glycoprotein.
Hanada, K; Ogata, H; Tochikura, N, 2007
)
1.38
"Tamsulosin is a potent, third-generation selective alpha(1A) adrenoceptor-blocking agent."( Tamsulosin MR and OCAS (modified release and oral controlled absorption system): current therapeutic uses.
Grey, AD; Nargund, VH, 2008
)
2.51
"Tamsulosin-HCl is an alpha1A-adrenoceptor antagonist that is mainly eliminated by metabolism in animals and humans and is highly bound to alpha1-acid glycoprotein in blood plasma. "( Disposition of the selective alpha1A-adrenoceptor antagonist tamsulosin in humans: comparison with data from interspecies scaling.
Higuchi, S; Matsushima, H; Soeishi, Y; van Hoogdalem, EJ, 1997
)
1.98
"Tamsulosin is an improvement over other alpha-adrenergic antagonists for the management of symptoms of benign prostatic hyperplasia. "( Tamsulosin for the treatment of benign prostatic hypertrophy.
Lee, M, 2000
)
3.19
"Tamsulosin is an alpha1-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia with a tolerability similar to that of placebo in short-term, placebo-controlled studies with limited patient numbers. "( A 6-month large-scale study into the safety of tamsulosin.
Bressel, HU; Goepel, M; Michel, MC; Rübben, H, 2001
)
2.01
"Tamsulosin is a selective alpha1A- and alpha1D-adrenoceptor antagonist. "( Tamsulosin: an update of its role in the management of lower urinary tract symptoms.
Jarvis, B; Lyseng-Williamson, KA; Wagstaff, AJ, 2002
)
3.2
"Tamsulosin is a subtype-selective alpha(1A)- and alpha(1D )-adrenoceptor antagonist. "( Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms.
Dunn, CJ; Faulds, DM; Matheson, A, 2002
)
3.2

Effects

Tamsulosin OCAS 0.4 mg has a favourable efficacy/safety profile and should be considered the treatment of choice for patients requiring optimal symptom control without increasing the risk of cardiovascular adverse events.

Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. The drug has a risk of complications of up to 80 % whereas doxazosin and alfuzosin only have a 15-20’% chance of complications.

ExcerptReferenceRelevance
"Tamsulosin has a risk of complications of up to 80 %, whereas doxazosin and alfuzosin only have a 15-20 % chance of complications. "( [Intraoperative floppy iris syndrom (IFIS) associated with tamsulosin].
Bigdon, E; Casagrande, M; Hassenstein, A; Spitzer, MS, 2022
)
2.41
"Tamsulosin OCAS 0.4 mg has a favourable efficacy/safety profile and should be considered the treatment of choice for patients requiring optimal symptom control without increasing the risk of cardiovascular adverse events."( Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Schulman, CC, 2008
)
3.23
"Tamsulosin has a markedly lower re-treatment percentage than alfuzosin and terazosin."( Long-term risk of re-treatment of patients using alpha-blockers for lower urinary tract symptoms.
de la Rosette, JJ; Floratos, DL; Kiemeney, LA; Kortmann, BB; Rossi, C; Sonke, GS, 2002
)
1.04
"Tamsulosin has a rapid onset of action and is effective in patients with moderate or severe symptoms."( Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms.
Dunn, CJ; Faulds, DM; Matheson, A, 2002
)
2.48
"Tamsulosin has more reversible adverse effect, compared to placebo (p = 0.03)."( A randomized trial of adjuvant tamsulosin as a medical expulsive therapy for renal stones after shock wave lithotripsy.
El-Assmy, AM; Elgamal, M; Elzalouey, AE; Hashem, A; Laymon, M; Sharaf, DE, 2022
)
1.73
"Tamsulosin has been associated with dementia, but the results have been inconsistent. "( Use of α1-adrenoceptor antagonists tamsulosin and alfuzosin and the risk of Alzheimer's disease.
Hartikainen, S; Latvala, L; Murtola, TJ; Tiihonen, M; Tolppanen, AM, 2022
)
2.44
"Tamsulosin has a risk of complications of up to 80 %, whereas doxazosin and alfuzosin only have a 15-20 % chance of complications. "( [Intraoperative floppy iris syndrom (IFIS) associated with tamsulosin].
Bigdon, E; Casagrande, M; Hassenstein, A; Spitzer, MS, 2022
)
2.41
"Tamsulosin has been used for the off-label treatment of lower urinary tract symptoms (LUTS) in women. "( Tamsulosin for treatment of lower urinary tract symptoms in women: a systematic review and meta-analysis.
Cheng, X; Huang, ZG; Liu, TT; Qiu, Y; Zhang, HL; Zou, XQ, 2017
)
3.34
"Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH."( Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial.
Bae, JH; Chang, IH; Chung, JH; Chung, JI; Ha, US; Han, DH; Han, JH; Jung, J; Kim, JH; Kim, SW; Kim, TH; Kim, YI; Lee, SH; Lee, SW; Oh, CY; Yoo, TK, 2018
)
1.51
"Tamsulosin has been the most commonly prescribed α1-blocker since the mid-2000s, in line with its demonstrated highest persistence and return rates."( Prescription pattern of alpha-blockers for management of lower urinary tract symptoms/benign prostatic hyperplasia.
Bae, WJ; Cho, HJ; Choi, JB; Ha, US; Han, K; Hong, SH; Kim, SW; Lee, JY; Moon, HW; Park, SH; Yang, JH, 2018
)
1.2
"Tamsulosin MR has been on the market for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) for many years. "( Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Schulman, CC, 2008
)
3.23
"Tamsulosin OCAS 0.4 mg has a favourable efficacy/safety profile and should be considered the treatment of choice for patients requiring optimal symptom control without increasing the risk of cardiovascular adverse events."( Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Schulman, CC, 2008
)
3.23
"Tamsulosin has beneficial effects in a significant proportion of women with voiding difficulty."( The effectiveness of tamsulosin in treating women with voiding difficulty.
Chang, SJ; Chiang, IN; Yu, HJ, 2008
)
2.11
"Tamsulosin has also shown promise in ameliorating (early) storage symptoms and urinary retention associated with transurethral microwave thermotherapy, external-beam radiotherapy, and brachytherapy."( The use of alpha1-adrenoceptor antagonists in lower urinary tract symptoms: beyond benign prostatic hyperplasia.
Nickel, JC, 2003
)
1.04
"Tamsulosin has selectivity for the a alpha(1) and alpha(1d) receptor subtypes. "( Role of the newer alpha, -adrenergic-receptor antagonists in the treatment of benign prostatic hyperplasia-related lower urinary tract symptoms.
Lowe, FC, 2004
)
1.77
"Tamsulosin has selective alpha1A-adrenoreceptor antagonistic properties and obviously binds for a long period to the postsynaptic nerve endings of the iris dilator muscle, thus affecting iris dilatation and leading to complications in cataract surgery. "( Influence of tamsulosin on the iris and its implications for cataract surgery.
Dugué, B; Keski-Rahkonen, P; Lehtonen, M; Leppänen, E; Mauriala, T; Pärssinen, O, 2006
)
2.15
"Tamsulosin has a markedly lower re-treatment percentage than alfuzosin and terazosin."( Long-term risk of re-treatment of patients using alpha-blockers for lower urinary tract symptoms.
de la Rosette, JJ; Floratos, DL; Kiemeney, LA; Kortmann, BB; Rossi, C; Sonke, GS, 2002
)
1.04
"Tamsulosin has not been associated with clinically significant changes in blood pressure in clinical trials."( Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms.
Dunn, CJ; Faulds, DM; Matheson, A, 2002
)
2.48
"Tamsulosin has a rapid onset of action and is effective in patients with moderate or severe symptoms."( Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms.
Dunn, CJ; Faulds, DM; Matheson, A, 2002
)
2.48

Actions

Tamsulosin for lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH) is limited. TamsulOSin may cause a higher incidence of ejaculatory disorders than naftopidil, although the efficacy of 0.2 mg tamsulasin may be better than that of 50 mg naftopsidil. Tamsulsin may increase the risk of dementia in older men with BPH.

ExcerptReferenceRelevance
"The tamsulosin group had lower failed URS (38% vs 61%, p = 0.20)."( The effect of preoperative tamsulosin on ureteroscopic access in school-aged children.
Kraft, KH; McGee, LM; Sack, BS; Wan, J, 2021
)
1.4
"The tamsulosin effect was lower with greater baseline PV and tended to decrease over time."( Understanding Treatment Response in Individual Profiles of Men with Prostatic Enlargement at Risk of Progression.
Averbeck, MA; Concas, F; Cortés, V; Gravas, S; Kamola, PJ; Kattan, MW; Lulic, Z; Manyak, M; Oelke, M; Palacios-Moreno, JM; Roehrborn, CG; Thompson, D, 2023
)
1.39
"tamsulosin for lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH) is limited."( Comparative Effectiveness of Tadalafil versus Tamsulosin in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostate Hyperplasia: A Meta-Analysis of Randomized Controlled Trials.
Chen, X; Guo, B; Hou, H; Liu, M; Wang, M; Zhang, Z, 2020
)
1.54
"Tamsulosin may increase the risk of dementia in older men with BPH."( Tamsulosin and the risk of dementia in older men with benign prostatic hyperplasia.
Albertsen, PC; Duan, Y; Grady, JJ; Helen Wu, Z, 2018
)
3.37
"Tamsulosin may also increase patient satisfaction by reducing the invasive treatment and decreasing the time to stone passage."( Tamsulosin for urolithiasis: a review of the recent literature and current controversies.
Mazer-Amirshahi, M; Nadendla, R; O'Connell, F; Pourmand, A, 2016
)
2.6
"Tamsulosin may cause a higher incidence of ejaculatory disorders than naftopidil, although the efficacy of 0.2 mg tamsulosin may be better than that of 50 mg naftopidil."( Ejaculatory disorders caused by alpha-1 blockers for patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: comparison of naftopidil and tamsulosin in a randomized multicenter study.
Furuya, R; Iwasawa, A; Masumori, N; Mori, M; Sonoda, T; Tsukamoto, T, 2009
)
1.99
"Tamsulosin can cause intraoperative floppy iris syndrome and increase the risk of phacoemulsification complications. "( Effect of timing and duration of tamsulosin exposure on complications in resident-performed phacoemulsification.
Han, Y; Ku, TK; Naseri, A; Porco, TC; Rutar, T,
)
1.86
"Tamsulosin alone did not cause any significant changes in comparison to placebo."( The effects of tamsulosin and sildenafil in separate and combined regimens on detailed hemodynamics in patients with benign prostatic enlargement.
Kähönen, M; Kööbi, T; Nieminen, T; Tammela, TL, 2006
)
1.41
"Tamsulosin may cause adverse ocular effects including recurrent choroidal detachments. "( Choroidal detachment following the use of tamsulosin (Flomax).
Flach, A; Lee, SE; McCaffery, S; O'Brien, JM; Petrovic, V; Shapiro, BL, 2007
)
2.05
"Tamsulosin improves lower urinary tract symptoms and flow. "( Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.
MacDonald, R; Nelson, D; Wilt, TJ, 2002
)
3.2

Treatment

Tamsulosin treatment (0.4 mg, h.s.) for 3 months not only improved voiding and storage symptoms, but also reduced nocturia episodes. In tamsulOSin treated patients, using modified corneal incisions may be feasible to reduce the incidence and severity of IFIS during cataract surgery.

ExcerptReferenceRelevance
"Tamsulosin treatment reduced the risk of POUR by two-thirds (odds ratio [OR], 0.337; 95% confidence interval [CI], 0.117-0.971; p=0.044)."( Preventive effects of tamsulosin for postoperative urinary retention after lower limb arthroplasty: A randomized controlled study.
Chang, JD; Choi, CI; Choo, MS; Han, JH; Kim, JK; Lee, SH, 2021
)
1.66
"The tamsulosin treatment period and pupil diameter during five stages of the surgery were also noted."( Modified Corneal Incisions for Cataract Surgery in Patients Treated with Tamsulosin: A Prospective Study.
Blau-Most, M; Geffen, N; Mimouni, M; Segal, O; Segev, F, 2019
)
1.23
"In tamsulosin treated patients, using modified corneal incisions may be feasible in order to reduce the incidence and severity of IFIS during cataract surgery. "( Modified Corneal Incisions for Cataract Surgery in Patients Treated with Tamsulosin: A Prospective Study.
Blau-Most, M; Geffen, N; Mimouni, M; Segal, O; Segev, F, 2019
)
1.37
"Tamsulosin treatment (0.4 mg, h.s.) for 3 months not only improved voiding and storage symptoms, but also reduced nocturia episodes. "( Male patients with a higher frequency of nocturnal urinary episodes are more likely to benefit from alpha-blocker therapy for bothersome nocturia.
Kuo, HC; Lee, CL, 2019
)
1.96
"Tamsulosin-treated patients had a 0.30-fold lower risk of developing acute urinary retention compared with control patients (95% confidence interval 0.12-0.76; P = 0.011)."( Impact of tamsulosin on urinary retention following early catheter removal after robot-assisted laparoscopic radical prostatectomy: a prospective randomized controlled trial.
Ahn, H; Choo, MS; Hong, JH; Hong, S; Jeong, IG; Kim, CS; Lim, JH; Yoon, JH; You, D, 2014
)
1.53
"Tamsulosin treatment should therefore be considered for patients with LUS."( A comparison of nifedipine and tamsulosin as medical expulsive therapy for the management of lower ureteral stones without ESWL.
Cao, D; Han, P; Liu, L; Lv, X; Qian, S; Wei, Q; Yang, L; Yuan, H, 2014
)
1.41
"The tamsulosin-treated patients dilated less with phenylephrine than controls (0.61±0.4 vs."( The differential pupillary response to 2.5% phenylephrine in patients taking tamsulosin.
Hillelsohn, JH; Hymowitz, MB; Liu, GT; Schultz, JS; Shrivastava, A, 2015
)
1.13
"Tamsulosin treatment seems to bring on the expulsion of distal ureteral stones, although at the expense of an appreciable risk of side effects."( [Tamsulosin efficacy and safety for conservative management of renal colic: systematic review and meta-analysis of randomized controlled trials].
Benítez Camps, M; Cerain Herrero, MJ; de Miguel Llorente, N; Flores Mateo, G; Martorell Sole, E; Murillo-Huapaya, C; Pedro Pijoan, AM, 2015
)
2.77
"Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones < or = 7 mm. "( Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial.
Frauenfelder, T; Hermanns, T; Rufibach, K; Sauermann, P; Strebel, RT; Sulser, T, 2009
)
2.12
"Tamsulosin treatment is recommended for patients with the stone diameter smaller than 8 mm because of its feasibility, effectiveness and safety. "( Comparison of tamsulosin with extracorporeal shock wave lithotripsy in treating distal ureteral stones.
Ding, ST; Lü, JJ; Lue, YH; Xia, QH; Zhang, H; Zhang, MY, 2009
)
2.16
"• Tamsulosin treatment resulted in a significant reduction in mean systolic blood pressure (-4.2 mmHg, within-group P= 0.004) relative to the negligible change of silodosin (-0.1 mmHg, within-group P= 0.96)"( Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Cheng, CL; Cheng, HL; Chiang, PH; Lin, AT; Tsui, KH; Wu, HC; Wu, TT; Yang, SS; Yu, HJ, 2011
)
1.21
"Tamsulosin OCAS® treatment led to significant improvements in LUTS, HUS and QoL in Thai patients with bladder outlet obstruction from BPH with few side effects."( The efficacy and safety of oral Tamsulosin controlled absorption system (OCAS) for the treatment of lower urinary tract symptoms due to bladder outlet obstruction associated with benign prostatic hyperplasia: an open-label preliminary study.
Lojanapiwat, B; Permpongkosol, S,
)
1.86
"Tamsulosin treatment was also associated with a significantly lower interval to the elimination of stone fragments (P < .001), a significantly lower rehospitalization rate (P < .001), and a significantly lower proportion of patients with acute renal colic (P < .05) than standard care alone."( Efficacy of tamsulosin oral controlled absorption system after extracorporeal shock wave lithotripsy to treat urolithiasis.
Dimitrov, PD; Georgiev, MI; Mladenov, VD; Ormanov, DI; Panchev, PK; Popov, EP; Simeonov, PP; Vassilev, VD, 2011
)
1.47
"Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates."( Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men.
Imaoka, T; Kim, SC; Morisaki, Y; Viktrup, L; Wang, CJ; Yokoyama, O; Yoshida, M, 2013
)
1.32
"Tamsulosin treatment was effective in 33 (68.7 %) patients at the first administration and 35 (72.9 %) at the third month."( The effect of first dose of tamsulosin on flow rate and its predictive ability on the improvement of LUTS in men with BPH in the mid-term.
Akin, Y; Gulmez, H; Ucar, M; Yucel, S, 2013
)
1.41
"Tamsulosin treatment of BPH patients for more than 12 months showed a sustained, stable efficacy. "( Long-term treatment outcome of tamsulosin for benign prostatic hyperplasia.
Arai, Y; Ichioka, K; Matsui, Y; Ohara, H; Terada, N; Terai, A; Yoshimura, K, 2004
)
2.05
"With tamsulosin treatment, both mesopic and scotopic PD decreased, respectively, from 3.9 +/- 0.7 and 5.7 +/- 0.6 mm at day 0 to 3.6 +/- 0.9 and 5.5 +/- 0.8 mm at day 28, and 3.6 +/- 0.7 and 5.4 +/- 0.7 mm at month 6 (ANOVA; P = 0.021 and = 0.040, respectively)."( The effects of two systemic alpha1-adrenergic blockers on pupil diameter: a prospective randomized single-blind study.
Adibelli, FM; Akova, YA; Altan-Yaycioglu, R; Gul, U; Pelit, A; Yaycioglu, O, 2007
)
0.79
"tamsulosin daily for the treatment of patients with symptoms of moderate to severe benign prostatic hyperplasia."( A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group.
Narayan, P; Tewari, A, 1998
)
1.24
"Men treated with tamsulosin having standard cataract extraction surgery were placed in a treatment group that received phenylephrine 1.0%-ketorolac 0.3% injection in the irrigation solution and a control group) that received basic saline solution. "( Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome.
Juzych, MS; Nariman, N; Pankratz, J; Rana, S; Rana, VK; Segars, L; Silverstein, SM; Stephens, R, 2018
)
1.07
"Treatment with tamsulosin did not differ from a control group in the overall incidence of side effects (RR 1.14, 95% CI 0.86-1.51, p = 0.36)."( Tamsulosin as a Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chand, H; Chen, H; Chen, J; Chen, M; Chen, Z; Cheng, X; Cui, Y; Hu, J; Li, C; Li, H; Li, Y; Liu, P; Yang, Z; Zeng, F; Zu, X, 2019
)
2.3
"Treatment with tamsulosin and tolterodine appears to be beneficial in intramural ureteral stone clearance, particularly in intramural ureter stone with symptoms of vesical irritability."( Tamsulosin and tolterodine in the medical expulsive therapy for intramural ureteral stones with vesical irritability: a prospective randomized study.
Lv, JL; Tang, Ql, 2013
)
2.17
"Treatment with tamsulosin is associated with improved LUTS and decreased depressive symptoms, which could enhance QoL."( Tamsulosin Treatment Affecting Patient-reported Outcomes in Benign Prostatic Hyperplasia-associated Depressive Symptoms.
Jang, EY; Kim, KS; Kim, YT; Moon, HS, 2016
)
2.23
"Pretreatment with tamsulosin at a dose of 0.4 microg/kg i.v."( The involvement of urothelial alpha1A adrenergic receptor in controlling the micturition reflex.
Kawatani, M; Momota, Y; Nimura, T; Wang, X; Yanase, H, 2008
)
0.67
"Treatment with tamsulosin improves the stone free rate and reduces the occurrence of colic episodes, after ureteroscopic laser lithotripsy of large renal and ureteric calculi. "( Adjunctive tamsulosin improves stone free rate after ureteroscopic lithotripsy of large renal and ureteric calculi: a prospective randomized study.
John, TT; Razdan, S, 2010
)
1.1
"Treatment with tamsulosin after ESWL appears to be effective in assisting stone clearance in patients with renal and ureteric calculi. "( alpha-Blockers to assist stone clearance after extracorporeal shock wave lithotripsy: a meta-analysis.
Duijvesz, D; Lock, TM; Rovers, MM; Zhu, Y, 2010
)
0.71
"Treatment with tamsulosin seemed to reduce the PSA levels and identified patients at high risk of prostate cancer."( Reduction of prostate-specific antigen after tamsulosin treatment in patients with elevated prostate-specific antigen and lower urinary tract symptoms associated with low incidence of prostate cancer at biopsy.
De Nunzio, C; Mariani, S; Miano, L; Miano, R; Trucchi, A; Tubaro, A; Vicentini, C, 2010
)
0.97
"Treatment with tamsulosin was effective in raising the success rate of voiding without catheter after an episode of acute urinary retention. "( [Tamsulosin in the treatment of benign prostatic hyperplasia patients with acute urinary retention].
Chen, SG; Hua, LX; Qian, LX; Sui, YG; Wu, HF; Xu, ZQ; Zhang, W, 2003
)
1.58
"Treatment with tamsulosin for symptomatic BPH patients is associated with significant improvement in the generic HRQOL, in addition to disease-specific QOL and symptoms, at 3 months after drug administration. "( Clinical impact of tamsulosin on generic and symptom-specific quality of life for benign prostatic hyperplasia patients: using international prostate symptom score and Rand Medical Outcomes Study 36-item Health Survey.
Awa, Y; Egoshi, K; Furuya, Y; Hamano, S; Ichikawa, T; Mikami, K; Nakatsu, H; Ohki, T; Okano, T; Ota, S; Suzuki, H; Yano, M, 2006
)
1.02
"Treatment with tamsulosin hydrochloride showed significant improvement of each IPSS and the bother score."( Effect of tamsulosin hydrochloride on lower urinary tract symptoms and quality of life in patients with benign prostatic hyperplasia. Evaluation using bother score.
Inadome, A; Maeda, Y; Masunaga, K; Nagata, T; Satoji, Y; Sugiyama, Y; Yoshida, M, 2007
)
1.08
"Treatment with tamsulosin for 12 weeks also produced significant improvements in average urinary flow rate (P = 0.040), irritative (P = 0.013) and obstructive (P = 0.014) symptom scores and symptoms of nocturia (P = 0.022) and hesitancy (P = 0.004)."( Tamsulosin, a selective alpha 1c-adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic 'obstruction' (symptomatic BPH). The European Tamsulosin Study Group.
Abrams, P; Schulman, CC; Vaage, S, 1995
)
2.07

Toxicity

Tamsulosin, dutasteride and imidafenacin combination therapy improves overactive bladder symptoms and quality of life without causing serious adverse drug reactions in patients with enlarged prostate. Higher overall treatment emergent adverse event rates were observed with tamsulOSin plus placebo.

ExcerptReferenceRelevance
" During the 60-week study period, 51 patients (21%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which were dizziness and abnormal ejaculation, both occurring in 5% of patients."( Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. Analysis of a multinational, multicentre, open-label study assessing the long-term efficacy and safety in patients with benign prostatic obstruction (symptomatic BPH). European Tam
Cortvriend, J; Jonas, U; Lock, TM; Schulman, CC; Speakman, MJ; Vaage, S, 1996
)
1.74
" Safety was evaluated by monitoring adverse events and vital signs (including 8 h after the first dose), and by laboratory determinations."( A dose-ranging study of the efficacy and safety of tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist, in patients with benign prostatic obstruction (symptomatic benign prostatic hyperplasia).
Abrams, P; Arkell, D; Pocock, R; Speakman, M; Stott, M, 1997
)
0.55
" During the 3-year study period, 95 patients (27%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which (occurring in ( Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: analysis of a European, multinational, multicenter, open-label study. European Tamsulosin Study Group.
Cortvriend, J; Jonas, U; Lock, TM; Schulman, CC; Speakman, MJ; Vaage, S, 1999
)
1.75
" No unknown adverse reactions were observed in either groups, and the drugs were shown to be highly safe."( [The efficacy and safety of terazosin and tamsulosin in patients with urinary disturbance accompanying prostatic hypertrophy].
Fujioka, T; Goto, Y; Isurugi, K; Katoh, T; Numasato, S; Obara, W; Omori, S; Suzuki, Y, 2001
)
0.57
"We systematically reviewed the effectiveness and adverse effects of tamsulosin for lower urinary tract symptoms compatible with benign prostatic obstruction."( Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.
MacDonald, R; Nelson, D; Wilt, TJ, 2002
)
1.99
" Treatment withdrawals and adverse effects increased markedly as the tamsulosin dose increased."( Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.
MacDonald, R; Nelson, D; Wilt, TJ, 2002
)
1.99
" Adverse effects were generally mild but the incidence, including treatment withdrawals, increased substantially at higher doses."( Tamsulosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.
MacDonald, R; Nelson, D; Wilt, TJ, 2002
)
1.76
" Six subjects experienced adverse events while receiving placebo and seven while on tamsulosin."( Effects of the concomitant administration of tamsulosin (0.8 mg) on the pharmacokinetic and safety profile of intravenous digoxin (Lanoxin) in normal healthy subjects: a placebo-controlled evaluation.
Forrest, A; Ito, Y; Kamimura, H; Miyazawa, Y; Paul Starkey, L; Schentag, JJ; Swarz, H, 2002
)
0.8
"To systematically review and evaluate the effectiveness and adverse effects of the alpha-antagonist, terazosin, for treating urinary symptoms associated with benign prostatic obstruction (BPO)."( Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effects.
Howe, W; MacDonald, R; Wilt, TJ, 2002
)
0.31
" Adverse effects were greater than with placebo and included dizziness, asthenia, headache and postural hypotension."( Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effects.
Howe, W; MacDonald, R; Wilt, TJ, 2002
)
0.31
" Adverse effects were generally mild but more frequent than with other alpha-antagonists and associated with a two- to four-fold increase in treatment discontinuation."( Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effects.
Howe, W; MacDonald, R; Wilt, TJ, 2002
)
0.31
" Some significant changes in vital signs and a number of mild adverse reactions were reported, but the overall safety profile of tamsulosin and theophylline was acceptable."( Effects of the concomitant administration of tamsulosin (0.8 mg/day) on the pharmacokinetic and safety profile of theophylline (5 mg/kg): a placebo-controlled evaluation.
Forrest, A; Ito, Y; Kamimura, H; Miyazawa, Y; Schentag, JJ; Starkey, LP; Swarz, H,
)
0.6
" Both doses of alfuzosin were well tolerated, with dizziness the most frequent adverse event (placebo, 4%; alfuzosin 10 mg, 6%; 15 mg, 7%; tamsulosin, 2%); the respective incidence rates of sexual function adverse events were 0%, 3%, 1% and 8%."( Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia.
Nordling, J, 2005
)
0.77
" The incidence of sexual function adverse events was higher with tamsulosin than with placebo."( Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia.
Nordling, J, 2005
)
0.8
" Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure."( Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial.
Gotoh, M; Kamihira, O; Kinukawa, T; Ohshima, S; Ono, Y; Origasa, H, 2005
)
0.69
" The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups."( Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial.
Gotoh, M; Kamihira, O; Kinukawa, T; Ohshima, S; Ono, Y; Origasa, H, 2005
)
0.69
"This study suggests that naftopidil is as effective and safe as tamsulosin."( Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial.
Gotoh, M; Kamihira, O; Kinukawa, T; Ohshima, S; Ono, Y; Origasa, H, 2005
)
0.93
" The incidence of adverse events was similar for tamsulosin (25%) and alfuzosin (19."( A comparative study on the safety and efficacy of tamsulosin and alfuzosin in the management of symptomatic benign prostatic hyperplasia: a randomized controlled clinical trial.
Acepcion, V; Lapitan, MC; Mangubat, J,
)
0.64
"alpha(1)-Blockers were effective and safe for treating young and middle-aged men with symptomatic bladder neck obstruction."( Obstructive primary bladder neck disease: evaluation of the efficacy and safety of alpha1-blockers.
Artibani, W; Calpista, A; Cisternino, A; De Marco, V; Iafrate, M; Prayer Galetti, T; Zeccolini, G, 2006
)
0.33
" The efficacy of two treatments was assessed every 2 weeks during treatment, and at the end of the study using responses to IIEF, VAS evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects."( Safety and efficacy of tamsulosin in the treatment of painful ejaculation: a randomized, double-blind, placebo-controlled study.
Safarinejad, MR,
)
0.44
" Both drugs were well tolerated, with one adverse event in 1514 treatment days for PRO 160/120 and one event in 1164 days for tamsulosin."( Efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms. A randomized, double-blind study versus tamsulosin.
Bondarenko, B; Engelmann, U; Funk, P; Schläfke, S; Walther, C, 2006
)
0.74
" The primary parameters used for safety evaluation were vital signs (blood pressure and heart rate) and adverse events."( Efficacy and safety of tamsulosin hydrochloride compared to doxazosin in the treatment of Indonesian patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
Birowo, P; Djati, W; Rahardjo, D; Soebadi, DM; Sugandi, S; Wahyudi, I, 2006
)
0.64
" Tamsulosin was well tolerated; only three patients (6%) in the tamsulosin group reported an adverse event (dizziness) while 11 patients (22%) in the doxazosin group reported an adverse event (dizziness), one of whom withdrew from the study."( Efficacy and safety of tamsulosin hydrochloride compared to doxazosin in the treatment of Indonesian patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
Birowo, P; Djati, W; Rahardjo, D; Soebadi, DM; Sugandi, S; Wahyudi, I, 2006
)
1.55
" Tamsulosin OCAS was well tolerated and the proportion of women discontinuing because of adverse events was low (4."( A randomized double-blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome.
Bolodeoku, J; Cardozo, L; Robinson, D; Terpstra, G, 2007
)
1.47
" Prazosin prevented hepatotoxicity when administered 1 h before a toxic paracetamol insult and importantly, when administered up to 1 h post paracetamol injection."( alpha(1)-Adrenoceptor antagonists prevent paracetamol-induced hepatotoxicity in mice.
Kitteringham, NR; Macdonald, I; Park, BK; Randle, LE; Sathish, JG; Williams, DP, 2008
)
0.35
" The adverse event profile was similar to that observed in the overall CombAT population, and drug-related adverse events were more common with combination therapy (26%) than with tamsulosin (15%) or dutasteride (9%)."( Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH.
Chung, BH; Major-Walker, K; Montorsi, F; Morrill, BB; Roehrborn, CG; Siami, P; Wilson, TH, 2009
)
0.82
" No studies have documented whether use of tamsulosin or other alpha-blocker drug therapies affect the risk of serious postoperative adverse events."( Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
Anderson, GM; Bell, CM; Bronskill, SE; Cernat, G; Fischer, HD; Gill, SS; Gruneir, A; Hatch, WV; Paterson, JM; Rochon, PA, 2009
)
0.94
"To assess the risk of adverse events following cataract surgery in older men prescribed tamsulosin or other alpha-blocking drugs used to treat BPH."( Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
Anderson, GM; Bell, CM; Bronskill, SE; Cernat, G; Fischer, HD; Gill, SS; Gruneir, A; Hatch, WV; Paterson, JM; Rochon, PA, 2009
)
0.9
" The risk of these adverse events was compared between men treated with tamsulosin or other alpha-blockers and men with no exposure to these medications in the year prior to cataract surgery."( Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
Anderson, GM; Bell, CM; Bronskill, SE; Cernat, G; Fischer, HD; Gill, SS; Gruneir, A; Hatch, WV; Paterson, JM; Rochon, PA, 2009
)
0.91
"3%) had an adverse event."( Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
Anderson, GM; Bell, CM; Bronskill, SE; Cernat, G; Fischer, HD; Gill, SS; Gruneir, A; Hatch, WV; Paterson, JM; Rochon, PA, 2009
)
0.68
"Exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events."( Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
Anderson, GM; Bell, CM; Bronskill, SE; Cernat, G; Fischer, HD; Gill, SS; Gruneir, A; Hatch, WV; Paterson, JM; Rochon, PA, 2009
)
1.06
" Thus, tulosine is a safe and effective drug for treatment of prostatic adenoma."( [Efficacy and safety of tulosine in patients with prostatic adenoma].
Gorilkovskiĭ, LM; Zingerenko, MB,
)
0.13
" Adverse events were monitored throughout the study."( Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2009
)
0.35
"The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth (7% and 3%, respectively) and dizziness (3% and 2%, respectively)."( Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency.
Fakhoury, A; Fincher, R; He, W; Kaplan, SA; McCammon, K, 2009
)
0.6
" After 8 weeks of treatment, treatment outcomes and adverse effects were evaluated."( Efficacy and safety of tamsulosin for the treatment of non-neurogenic voiding dysfunction in females: a 8-week prospective study.
Choo, MS; Han, DH; Jeong, H; Kim, H; Lee, KS; Lee, SJ; Lee, YS; Park, HJ; Park, WH; Yoo, TK; Yoon, H, 2010
)
0.67
" Adverse events of tamsulosin also showed no significant difference from the placebo group (Z=1."( Efficacy and safety of tamsulosin for the treatment of benign prostatic hyperplasia: a meta analysis.
Kou, M; Lan, XX; Ren, RM, 2010
)
1
" Adverse events of tamsuloisn show no significant difference compared with placebo."( Efficacy and safety of tamsulosin for the treatment of benign prostatic hyperplasia: a meta analysis.
Kou, M; Lan, XX; Ren, RM, 2010
)
0.67
" No serious adverse events (SAE) were recorded during the study."( Long-term efficacy and safety of tamsulosin hydrochloride for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia: data from China.
Ji, JT; Liu, ZY; Shao, Y; Sun, YH; Wu, YY; Xu, CL; Zhang, LM; Zhang, ZS, 2011
)
0.65
" No patient reported any serious (grade ≥ 2) adverse event (AE)."( A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Carini, M; Gacci, M; Lapini, A; Maggi, M; Rossetti, MA; Serni, S; Siena, G; Tosi, N; Vignozzi, L; Vittori, G, 2012
)
0.6
" No adverse events were reported."( Efficacy and safety of orally disintegrating tamsulosin tablets in Taiwanese patients with benign prostatic hyperplasia.
Lee, LM; Lin, KH; Lin, YW; Wen, YC, 2012
)
0.64
" α(1) Blockers generally lead to more adverse effects compared with placebo, and those caused by terazosin were more frequent than others."( The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews.
Liu, Y; Mao, C; Qin, X; Yang, K; Yang, Z; Yuan, J, 2013
)
0.39
" The adverse effects caused by α(1) blockers are generally mild and well-tolerated."( The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews.
Liu, Y; Mao, C; Qin, X; Yang, K; Yang, Z; Yuan, J, 2013
)
0.39
" Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds."( Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).
Angulo, JC; Garcia-Hernandez, A; Haab, F; Katona, F; Klaver, M; Oelke, M; Traudtner, K; Van Kerrebroeck, P; Vik, V, 2013
)
0.66
"Combined tamsulosin and imidafenacin treatment is effective and safe in patients with BPH with persistent OAB symptoms after tamsulosin monotherapy."( Clinical efficacy and safety of imidafenacin as add-on treatment for persistent overactive bladder symptoms despite α-blocker treatment in patients with BPH: the ADDITION study.
Gotoh, M; Masumori, N; Nishizawa, O; Takahashi, S; Takeda, M; Yoshida, M, 2013
)
0.81
" Safety assessment included laboratory tests and patient's reporting of adverse event."( A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
Mandal, AK; Mete, UK; Singh, DV; Singh, SK, 2014
)
0.62
"Dutasteride can be used to improve urinary symptoms (IPSS and Q max) and reduce TPV but with awareness of its potential adverse events."( Efficacy and safety of dutasteride for the treatment of symptomatic benign prostatic hyperplasia (BPH): a systematic review and meta-analysis.
Choi, JY; Park, T, 2014
)
0.4
" But most adverse events were mild in degree."( [Clinical effectiveness and safety of combined therapy with alpha-blocker and an anticholinergic drug for bladder outlet obstruction with overactive bladder: a Meta-analysis of outcomes].
Li, J; Liu, B; Wang, Y; Wu, Y, 2014
)
0.4
"Alpha-blocker combined with an anticholinergic drug in the treatment of BOO+OAB was better than that of alpha-blocker alone, and was safe and well tolerated."( [Clinical effectiveness and safety of combined therapy with alpha-blocker and an anticholinergic drug for bladder outlet obstruction with overactive bladder: a Meta-analysis of outcomes].
Li, J; Liu, B; Wang, Y; Wu, Y, 2014
)
0.4
" Treatment-emergent adverse events were reported in 499 (46."( Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.
Chapple, C; Drake, MJ; Drogendijk, T; Klaver, M; Oelke, M; Sokol, R; Traudtner, K; Van Kerrebroeck, P, 2015
)
0.64
" We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention (UR), adverse events."( Efficacy and safety of solifenacin plus tamsulosin oral controlled absorption system in men with lower urinary tract symptoms: a meta-analysis.
Guo, XL; Li, MC; Liu, JH; Wang, SG; Wang, T; Wang, ZY; Yang, J; Ye, ZQ,
)
0.4
" In addition, tamsulosin is well tolerated, and its adverse events rarely led to dropouts of patients."( The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chen, K; Liu, L; Lv, T; Meng, Q; Mi, H; Sun, X; Wang, S; Xu, G, 2015
)
1.07
"Overall, evidence suggests that tamsulosin combined with SWL is safe and effective in enhancing stone expulsion for patients with urolithiasis."( The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chen, K; Liu, L; Lv, T; Meng, Q; Mi, H; Sun, X; Wang, S; Xu, G, 2015
)
1
"Systematic searches were conducted on PubMed, SCOPUS and The Cochrane Library so as to identify randomized and controlled clinical trials in patients treated with tamsulosin with ureteral stone expulsion and adverse events published until 2014 December, without language restriction."( [Tamsulosin efficacy and safety for conservative management of renal colic: systematic review and meta-analysis of randomized controlled trials].
Benítez Camps, M; Cerain Herrero, MJ; de Miguel Llorente, N; Flores Mateo, G; Martorell Sole, E; Murillo-Huapaya, C; Pedro Pijoan, AM, 2015
)
1.52
"Alfuzosin has been widely used to treat benign prostatic hyperplasia and prostatitis, and is claimed to be a selective agent for the lower urinary tract with low incidence of adverse side-effects and hypotensive changes."( Efficacy and Safety of Alfuzosin as Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Meta-Analysis.
Chen, K; Kang, R; Li, J; Liu, C; Wan, SP; Wu, W; Zeng, G, 2015
)
0.42
"Alfuzosin is a safe and effective agent for the expulsive therapy of ureteral stones smaller than 10 mm in size."( Efficacy and Safety of Alfuzosin as Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Meta-Analysis.
Chen, K; Kang, R; Li, J; Liu, C; Wan, SP; Wu, W; Zeng, G, 2015
)
0.42
"The aim of the study is to present the effects of BPH pharmacological treatment on the occurrence of sexually adverse effects in men: changes in sexual desire, erectile, ejaculatory and the orgasmic function."( Adverse Effects of Pharmacological Therapy of Benign Prostatic Hyperplasia on Sexual Function in Men.
Bogdanović, D; Djenić, N; Ignjatović, I; Stojanović, N,
)
0.13
" The main adverse effect on sexual function in men is the deterioration in ejaculation or the absence thereof."( Adverse Effects of Pharmacological Therapy of Benign Prostatic Hyperplasia on Sexual Function in Men.
Bogdanović, D; Djenić, N; Ignjatović, I; Stojanović, N,
)
0.13
" Adverse events occurred more frequently with silodosin than with tamsulosin; however, none of the adverse events required treatment discontinuation."( Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Arai, Y; Chiba, K; Horiuchi, S; Moriyama, S; Noro, A; Saito, K; Takeshita, H; Washino, S, 2016
)
0.89
" Safety was analyzed using adverse events."( Is Tamsulosin 0.2 mg Effective and Safe as a First-Line Treatment Compared with Other Alpha Blockers?: A Meta-Analysis and a Moderator Focused Study.
Chang, IH; Hwang, SD; Kim, JH; Kim, KH; Shim, SR; Shin, IS; Song, YS; Yoon, SJ, 2016
)
1.06
"2 mg has similar efficacy and fewer adverse events compared with other alpha-blockers as an initial treatment strategy for men with lower urinary tract symptoms."( Is Tamsulosin 0.2 mg Effective and Safe as a First-Line Treatment Compared with Other Alpha Blockers?: A Meta-Analysis and a Moderator Focused Study.
Chang, IH; Hwang, SD; Kim, JH; Kim, KH; Shim, SR; Shin, IS; Song, YS; Yoon, SJ, 2016
)
1.06
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
" After 4 weeks of medication, we compared the clinical global impression of change (CGIC) , PE profile (PEP) scores, intravaginal ejaculation latency time (IELT) , and adverse reactions between the two groups of patients."( [Efficacy and safety of dapoxetine in the treatment of premature ejaculation].
Chen, XY; Qu, YW; Wang, SG, 2016
)
0.43
" The incidence of adverse reactions was significantly lower in the dapoxetine than in the control group (3."( [Efficacy and safety of dapoxetine in the treatment of premature ejaculation].
Chen, XY; Qu, YW; Wang, SG, 2016
)
0.43
"Dapoxetine is effective for the treatment of PE, with its advantages of prolonging the intravaginal ejaculation latency time, improving the quality of sexual life, and low incidence of adverse reactions."( [Efficacy and safety of dapoxetine in the treatment of premature ejaculation].
Chen, XY; Qu, YW; Wang, SG, 2016
)
0.43
" Adverse events (AEs) were not increased with treatment progression."( Efficacy and Safety of Medium-to-long-term Use of Tolterodine Extended Release with or without Tamsulosin in Patients with Benign Prostate Hyperplasia and Larger Prostate Size: A Double-blind, Placebo-controlled, Randomized Clinical Trial.
Cai, JL; Jing, S; Na, YQ; Yan, YF; Yang, Y; Zhou, Z, 2016
)
0.65
"Tamsulosin, dutasteride and imidafenacin combination therapy improves overactive bladder symptoms and quality of life without causing serious adverse drug reactions in patients with enlarged prostate not responding to tamsulosin."( Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open-label, controlled trial (DIrecT Study)
Asakura, H; Seki, N; Tokunaga, S; Yamanishi, T, 2017
)
2.15
"Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated."( Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.
Iyer, G; Marimuthu, SP; Segal, JB; Singh, S, 2017
)
0.71
"We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013)."( Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.
Iyer, G; Marimuthu, SP; Segal, JB; Singh, S, 2017
)
0.96
" The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24."( Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial.
Ahn, TY; Hyun, JS; Jung, J; Kim, SW; Lee, SW; Min, KS; Moon, DG; Moon, KH; Park, JK; Park, K; Park, NC; Ryu, JK; Son, H; Yang, DY; Yang, SK, 2017
)
0.7
" No clinically significant adverse events regarding the investigational products were observed during the 24-week period."( Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial.
Ahn, TY; Hyun, JS; Jung, J; Kim, SW; Lee, SW; Min, KS; Moon, DG; Moon, KH; Park, JK; Park, K; Park, NC; Ryu, JK; Son, H; Yang, DY; Yang, SK, 2017
)
0.7
" The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks."( Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial.
Bae, JH; Chang, IH; Chung, JH; Chung, JI; Ha, US; Han, DH; Han, JH; Jung, J; Kim, JH; Kim, SW; Kim, TH; Kim, YI; Lee, SH; Lee, SW; Oh, CY; Yoo, TK, 2018
)
0.79
" No patients experienced any serious adverse effects in any of the three groups."( Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial.
Bae, JH; Chang, IH; Chung, JH; Chung, JI; Ha, US; Han, DH; Han, JH; Jung, J; Kim, JH; Kim, SW; Kim, TH; Kim, YI; Lee, SH; Lee, SW; Oh, CY; Yoo, TK, 2018
)
0.79
" We did not observe any adverse events or significant endothelial cell loss (p = 0."( Efficacy and safety of low-concentration, bisulphite-containing, intracameral epinephrine and topical atropine treatments for the prevention of intraoperative floppy iris syndrome.
Bulut, AE; Esen, F; Toker, E, 2018
)
0.48
"Concomitant TURBT and TURP appear to be oncologically safe procedures in terms of total and prostatic urethra recurrence, and improve QL in men with BC who require surgery for symptomatic BPH."( Oncological safety and quality of life in men undergoing simultaneous transurethral resection of bladder tumor and prostate: results from a randomized controlled trial.
Branchi, A; Castellani, D; Claudini, R; Dellabella, M; Gasparri, L, 2018
)
0.48
" Patients discontinued tamsulosin primarily because of adverse events (AEs) or insufficient response."( Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children.
Chughtai, BI; Kaplan, SA, 2018
)
1.19
" Even though tamsulosin has a higher incidence of retrograde ejaculation than placebo, no significant difference was observed in the incidence of other adverse events."( Efficacy and Safety of Tamsulosin in the Medical Expulsion Therapy for Distal Ureteral Calculi: A Systematic Review and Meta-Analysis of Placebo-Controlled Trials.
Liu, FD; Lv, JL; Qin, ZQ; Tao, RZ, 2019
)
1.19
" It should be a safe and effective medical expulsive therapy choice for distal ureteral stones when stone sizes are less than 10 mm."( Efficacy and Safety of Tamsulosin in the Medical Expulsion Therapy for Distal Ureteral Calculi: A Systematic Review and Meta-Analysis of Placebo-Controlled Trials.
Liu, FD; Lv, JL; Qin, ZQ; Tao, RZ, 2019
)
0.82
" For safety, combination-therapy had a higher incidence rate of any adverse events (AEs) and discontinuation due to AEs than monotherapy with the exception of pain."( Meta-Analysis of Efficacy and Safety of Tadalafil Plus Tamsulosin Compared with Tadalafil Alone in Treating Men with Benign Prostatic Hyperplasia and Erectile Dysfunction.
Cui, Y; Gao, Z; Wu, J; Xu, Z; Zheng, X; Zhou, Z,
)
0.38
"Short-term utilisation of Tamsulosin as MET in second and third trimester of pregnancy is not associated with adverse maternal or infant outcomes."( Safety and efficacy of Tamsulosin as medical expulsive therapy in pregnancy.
Cloutier, J; Morin, F; Theriault, B, 2020
)
1.17
" Safety assessments included treatment emergent adverse events, and post-void residual volume, and maximum urinary flow measurements."( Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).
Cambronero Santos, J; Chapple, C; Choudhury, N; Foley, S; Hairston, J; Herschorn, S; Kaplan, SA; Kristy, RM; McVary, KT; Schermer, CR; Staskin, D, 2020
)
0.77
" Higher overall treatment emergent adverse event rates were observed with tamsulosin plus placebo, although higher rates of drug related treatment emergent adverse events were noted with tamsulosin plus mirabegron."( Efficacy and Safety of Mirabegron versus Placebo Add-On Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: A Randomized, Phase 4 Study (PLUS).
Cambronero Santos, J; Chapple, C; Choudhury, N; Foley, S; Hairston, J; Herschorn, S; Kaplan, SA; Kristy, RM; McVary, KT; Schermer, CR; Staskin, D, 2020
)
1
"To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia."( Men's Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of
Giuliano, F; Lulic, Z; Manyak, MJ; Palacios-Moreno, JM; Roehrborn, CG; Rosen, RC; Wilson, TH, 2020
)
0.76
" Safety assessments that included treatment-emergent adverse events (odds ratio = 0."( The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: A systematic review and meta-analysis.
Chen, Z; Gao, Y; Liang, L; Lin, J; Liu, L; Su, S, 2020
)
0.77
"This analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy with a low occurrence of side effects."( The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: A systematic review and meta-analysis.
Chen, Z; Gao, Y; Liang, L; Lin, J; Liu, L; Su, S, 2020
)
0.97
"The adverse effects were minor and were managed symptomatically without any drug discontinuity."( Efficacy and safety of tadalafil vs tamsulosin in lower urinary tract symptoms (LUTS) as a result of benign prostate hyperplasia (BPH)-open label randomised controlled study.
Gupta, S; Singh, I; Tk, A, 2020
)
0.83
" The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
0.87
"Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group)."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
1.06
"Cardiovascular-related adverse events were uncommon in both treatment groups."( Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.
Ishida, K; Jong, JJ; Kakizaki, H; Katoh, T; Katou, D; Lee, KS; Sumarsono, B; Uno, S; Yamaguchi, O; Yamamoto, O, 2021
)
0.87
" An analysis of safety outcomes revealed extremely high adverse events (AEs) and pain in the combination group."( Efficacy and Safety of Combination Comprising Tamsulosin and PDE5-Is, Relative to Monotherapies, in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction Associated With Benign Prostatic Hyperplasia: A Meta-Analysis.
Sun, F; Sun, K; Wang, J; Wang, T; Wu, G; Wu, J; Yao, H; Zhang, D,
)
0.39
"To describe the otorhinolaryngological adverse effects of the main drugs used in urological practice."( Otorhinolaryngological adverse effects of urological drugs.
Ganança, FF; Lopes, KC; Maia, NPD,
)
0.13
"A review of the scientific literature was performed using a combination of specific descriptors (side effect, adverse effect, scopolamine, sildenafil, tadalafil, vardenafil, oxybutynin, tolterodine, spironolactone, furosemide, hydrochlorothiazide, doxazosin, alfuzosin, terazosin, prazosin, tamsulosin, desmopressin) contained in publications until April 2020."( Otorhinolaryngological adverse effects of urological drugs.
Ganança, FF; Lopes, KC; Maia, NPD,
)
0.31
"The main drugs used in Urology may cause several otorhinolaryngological adverse effects."( Otorhinolaryngological adverse effects of urological drugs.
Ganança, FF; Lopes, KC; Maia, NPD,
)
0.13
"Most of the drugs used in urological practice have otorhinolaryngological adverse effects."( Otorhinolaryngological adverse effects of urological drugs.
Ganança, FF; Lopes, KC; Maia, NPD,
)
0.13
" Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency (NF), PVR and IPSS, while safety was assessed by recording treatment emergent adverse events (TEAE)."( Efficacy and safety of tamsulosin vs its combination with mirabegron in the management of lower urinary tract non-neurogenic overactive bladder symptoms (OABS) because of Benign Prostatic Enlargement (BPE)-An open label randomised controlled clinical stud
Behera, DP; Gupta, S; Singh, I; T K, A, 2021
)
0.93
"Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE vs placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol."( Efficacy and safety of tamsulosin vs its combination with mirabegron in the management of lower urinary tract non-neurogenic overactive bladder symptoms (OABS) because of Benign Prostatic Enlargement (BPE)-An open label randomised controlled clinical stud
Behera, DP; Gupta, S; Singh, I; T K, A, 2021
)
0.93
" We sought to define the safe threshold of force for the passage of a ureteral access sheath using a novel ureteral access sheath force sensor."( Determining the Safety Threshold for the Passage of a Ureteral Access Sheath in Clinical Practice Using a Purpose-Built Force Sensor.
Clayman, RV; Cottone, C; Jiang, P; Kaler, KS; Klopfer, MJ; Landman, J; Lu, S; Okhunov, Z; Patel, RM; Tapiero, S, 2021
)
0.62
" The frequency, duration of treatment and risk of any adverse event (AE) or serious AE (SAE) was compared for combination therapy versus each monotherapy using non-inferiority testing."( Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database.
Bhak, RH; Cortes, V; Cunnington, M; Duh, MS; Kapse, P; Lulic, Z; Miller, D; Park, S; Son, H; Yoo, SB, 2021
)
0.89
" The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, Chinese Medicine Symptoms Score (CMSS), expressed prostatic secretions (EPS) and adverse events (AEs)."( Efficacy and Safety of Guihuang Formula in Treating Type III Prostatitis Patients with Dampness-Heat and Blood Stasis Syndrome: A Randomized Controlled Trial.
Deng, YJ; Gao, QH; Guo, J; Liu, SJ; Zeng, Y; Zhao, M, 2022
)
0.72
"Preoperative tamsulosin can not only increase the one-time success rate of ureteral navigation and the stone-free rate of URS but also reduce the incidence of postoperative adverse symptoms such as postoperative fever and postoperative pain."( The Effect of Preoperative Tamsulosin on Ureteral Navigation, Operation, and Safety: A Systematic Review and Meta-Analysis.
Cheng, C; Jin, X; Ma, Y; Wen, J; Xiang, L, 2023
)
1.58
"Patients on alpha-blockers (ABs) treatment may have an increased risk of adverse events (AEs)."( Adverse events related to alpha-blockers: analysis of real-life data from Eudra-Vigilance.
Baldassarri, V; Cicione, A; D'Annunzio, S; DE Nunzio, C; Franco, A; Guarnotta, G; Lombardo, R; Mancini, E; Nacchia, A; Rovesti, LM; Tema, G; Tubaro, A; Voglino, OA, 2023
)
0.91
"Eudra-Vigilance (EV) database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA)."( Adverse events related to alpha-blockers: analysis of real-life data from Eudra-Vigilance.
Baldassarri, V; Cicione, A; D'Annunzio, S; DE Nunzio, C; Franco, A; Guarnotta, G; Lombardo, R; Mancini, E; Nacchia, A; Rovesti, LM; Tema, G; Tubaro, A; Voglino, OA, 2023
)
0.91

Pharmacokinetics

The pharmacokinetics of tamsulosin hydrochloride (HCl) have been extensively studied in adults, but no pharmacokinetic data for paediatrics have been published to date. A radioreceptor assay has been developed for alpha1-adrenoceptor subtypes. Saliva and plasma samples were collected for 3-5 half-life values of sitagliptin, cinacalcet, metformin, montelukast and losartan.

ExcerptReferenceRelevance
" Mean Cmax and AUC of unbound drug (Cmax,u and AUCu), however, were almost the same in the two groups."( Pharmacokinetics of tamsulosin hydrochloride in patients with renal impairment: effects of alpha 1-acid glycoprotein.
Akaza, H; Aoyagi, K; Higuchi, S; Ito, M; Kamimura, H; Kikuchi, K; Koiso, K; Matsushima, H; Miyazaki, M; Ohba, S; Sueyoshi, T; Watanabe, T, 1996
)
0.62
" To test this hypothesis, we conducted three randomized, double-masked, placebo-controlled studies to evaluate how coadministration of tamsulosin would affect the pharmacodynamic profiles of nifedipine, enalapril, and atenolol."( Coadministration of tamsulosin and three antihypertensive agents in patients with benign prostatic hyperplasia: pharmacodynamic effect.
Lowe, FC,
)
0.66
"A radioreceptor assay has been developed for alpha1-adrenoceptor subtypes and applied to a pharmacokinetic analysis of tamsulosin and terazosin."( Radioreceptor assay analysis of tamsulosin and terazosin pharmacokinetics.
Michel, MC; Schäfers, RF; Taguchi, K, 1998
)
0.79
"8 mg) affects the pharmacokinetic and safety profile of intravenous digoxin (0."( Effects of the concomitant administration of tamsulosin (0.8 mg) on the pharmacokinetic and safety profile of intravenous digoxin (Lanoxin) in normal healthy subjects: a placebo-controlled evaluation.
Forrest, A; Ito, Y; Kamimura, H; Miyazawa, Y; Paul Starkey, L; Schentag, JJ; Swarz, H, 2002
)
0.57
" Theophylline and tamsulosin pharmacokinetic data were determined following administration of the drugs on days 1 and 9 and day 9, respectively."( Effects of the concomitant administration of tamsulosin (0.8 mg/day) on the pharmacokinetic and safety profile of theophylline (5 mg/kg): a placebo-controlled evaluation.
Forrest, A; Ito, Y; Kamimura, H; Miyazawa, Y; Schentag, JJ; Starkey, LP; Swarz, H,
)
0.72
"To evaluate pharmacokinetic and pharmacodynamic interactions between tamsulosin and acenocoumarol."( A placebo-controlled pharmacodynamic and pharmacokinetic interaction study between tamsulosin and acenocoumarol.
Clarke, C; Mullins, F; Rolan, P; Terpstra, IJ; Visser, JN, 2003
)
0.78
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The pharmacokinetics of tamsulosin are not affected to a major extent by age, and pharmacokinetic alterations in renally impaired patients relate largely to an increased concentration of alpha(1)-acid glycoprotein."( Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral controlled absorption system formulations.
de la Rosette, JJ; Franco-Salinas, G; Michel, MC, 2010
)
0.93
" The pharmacokinetics of tamsulosin hydrochloride (HCl) have been extensively studied in adults, but no pharmacokinetic data for paediatrics have been published to date."( Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder.
Higuchi, S; Ieiri, I; Liesenfeld, KH; Sarashina, A; Schäfer, HG; Staab, A; Tadayasu, Y; Tatami, S; Tsuda, Y; Yamamura, N, 2010
)
0.95
"A population pharmacokinetic model of tamsulosin HCl was developed in paediatric patients."( Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder.
Higuchi, S; Ieiri, I; Liesenfeld, KH; Sarashina, A; Schäfer, HG; Staab, A; Tadayasu, Y; Tatami, S; Tsuda, Y; Yamamura, N, 2010
)
0.92
"A population pharmacokinetic model of tamsulosin HCl in paediatric patients was established and it described the data well."( Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder.
Higuchi, S; Ieiri, I; Liesenfeld, KH; Sarashina, A; Schäfer, HG; Staab, A; Tadayasu, Y; Tatami, S; Tsuda, Y; Yamamura, N, 2010
)
0.92
"The Mean ± SD of pharmacokinetic parameters tmax, Cmax, AUC24, AUClast and AUCinf for Tamsulosin were 11."( A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects.
Arora, R; Arora, V; Balaji, A; Jha, D; Madan, S; Monif, T; Thudi, NR, 2010
)
0.58
" However, data on potential drug-drug interactions between tamsulosin and inhibitors of CYP2D6 and 3A4 are limited and information on potential pharmacodynamic consequences of such pharmacokinetic interactions is missing."( Effects of strong CYP2D6 and 3A4 inhibitors, paroxetine and ketoconazole, on the pharmacokinetics and cardiovascular safety of tamsulosin.
Mattheus, M; Mehlburger, L; Michel, MC; Tatami, S; Troost, J; Tsuda, Y; Wein, M, 2011
)
0.82
"85), respectively, and increased the terminal half-life (t(1/2) ) of tamsulosin HCl from 11."( Effects of strong CYP2D6 and 3A4 inhibitors, paroxetine and ketoconazole, on the pharmacokinetics and cardiovascular safety of tamsulosin.
Mattheus, M; Mehlburger, L; Michel, MC; Tatami, S; Troost, J; Tsuda, Y; Wein, M, 2011
)
0.81
" Saliva and plasma samples were collected for 3-5 half-life values of sitagliptin, cinacalcet, metformin, montelukast, tolterodine, hydrochlorothiazide (HCT), lornoxicam, azithromycin, diacerhein, rosuvastatin, cloxacillin, losartan and tamsulosin after oral dosing."( Saliva versus plasma pharmacokinetics: theory and application of a salivary excretion classification system.
Arafat, T; Idkaidek, N, 2012
)
0.56
" The validated method was successfully applied to a pharmacokinetic study in humans."( Determination of tamsulosin in human plasma by liquid chromatography/tandem mass spectrometry and its application to a pharmacokinetic study.
Bae, JW; Byeon, JY; Choi, CI; Jang, CG; Lee, HI; Lee, SY; Lee, YJ, 2012
)
0.72
" The levofloxacin concentrations were detected by high performance liquid chromatography (HPLC), and the pharmacokinetic parameters were calculated using the 3p97 software program."( Tamsulosin alters levofloxacin pharmacokinetics in prostates derived from rats with acute bacterial prostatitis.
He, HX; He, Y; Qin, GD; Xiao, MZ; Yang, J; Zeng, Y; Zhou, YD, 2013
)
1.83
"The primary aim of this study was to evaluate whether there was clinically significant pharmacokinetic (PK) interaction between finasteride and tamsulosin in healthy Chinese male subjects."( Pharmacokinetic interaction of finasteride with tamsulosin hydrochloride: an open-label, randomized, 3-period crossover study in healthy Chinese male volunteers.
Chen, W; Chu, N; Li, X; Wang, G; Wang, J; Xu, H; Yang, M; Yuan, F, 2015
)
0.87
" Pharmacokinetic parameters were estimated via noncompartmental methods."( Pharmacokinetic interaction of finasteride with tamsulosin hydrochloride: an open-label, randomized, 3-period crossover study in healthy Chinese male volunteers.
Chen, W; Chu, N; Li, X; Wang, G; Wang, J; Xu, H; Yang, M; Yuan, F, 2015
)
0.67
" In the presence or absence of tamsulosin, there were no apparent changes in dutasteride AUC and Cmax ."( Effect of tamsulosin on the pharmacokinetics of dutasteride in Chinese male healthy volunteers.
Fossler, MJ; Li, H; Wang, C; Yang, J; Zhao, H, 2015
)
1.11
" This study aims to develop and validate the physiologically based pharmacokinetic (PBPK) model of tamsulosin in CYP2D6*wt/*wt, CYP2D6*wt/*10, and CYP2D6*10/*10 genotypes, using Simcyp® simulator."( Physiologically based pharmacokinetic (PBPK) modelling of tamsulosin related to CYP2D6*10 allele.
Bae, JW; Cho, CK; Jang, CG; Kang, P; Lee, SY; Lee, YJ; Park, HJ, 2021
)
1.08

Compound-Compound Interactions

Tamsulosin can effectively relieve prostatitis pain, improve erectile function, lessen anxiety and depression symptoms, increase the level of lecithosomes.

ExcerptReferenceRelevance
" The efficacy and prostate reduction of an anti-androgenic agent, chlormadinone acetate, combined with alpha adrenergic blocker, tamsulosin hydrochloride, were evaluated using 40-BPH patients insufficiently treated with tamsulosin hydrochloride alone."( [Clinical efficacy and reduction effect on prostatic volume of chlormadinone acetate combined with tamsulosin hydrochloride in benign prostatic hyperplasia patients insufficiently treated with tamsulosin hydrochloride only].
Asari, T; Egawa, M; Haginaka, T; Kameda, K; Katsumi, T; Kawaguchi, K; Miyazaki, K; Murayama, K; Nishino, A; Sakai, A; Ueki, O, 1998
)
0.72
"To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men."( Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: randomized, double-blind, placebo-controlled study.
Aquilina, JW; Armstrong, RB; Chen, A; MacDiarmid, SA; Nitti, VW; Orman, C; Peters, KM, 2008
)
0.79
"Tamsulosin combined with extended-release oxybutynin resulted in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 (P=."( Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: randomized, double-blind, placebo-controlled study.
Aquilina, JW; Armstrong, RB; Chen, A; MacDiarmid, SA; Nitti, VW; Orman, C; Peters, KM, 2008
)
2.02
"To investigate the clinical efficacy of Shuganyiyang Capsule combined with conventional Western medicine (tamsulosin hydrochloride sustained release tablets + prostat tablets) for the treatment of type III prostatitis complicated by erectile dysfunction (ED)."( [Clinical efficacy of Shuganyiyang capsule combined with Western medicine for the treatment of type III prostatitis complicated by erectile dysfunction].
Chen, L; Feng, YG; Zhou, ZH, 2013
)
0.6
"Eighty patients with type III prostatitis complicated by ED were equally randomized to an experimental and a control group, the former treated with Shuganyiyang Capsule combined with tamsulosin hydrochloride sustained release tablets and prostat tablets, while the latter with tamsulosin hydrochloride and prostat only, both for 8 weeks."( [Clinical efficacy of Shuganyiyang capsule combined with Western medicine for the treatment of type III prostatitis complicated by erectile dysfunction].
Chen, L; Feng, YG; Zhou, ZH, 2013
)
0.58
"Shuganyiyang Capsule combined with conventional Western medicine, such as alpha blockers and galenica, produces definite effect on chronic prostatitis complicated by ED, improves the psychological conditions of the patient, and enhances the therapeutic efficiency of chronic prostatits."( [Clinical efficacy of Shuganyiyang capsule combined with Western medicine for the treatment of type III prostatitis complicated by erectile dysfunction].
Chen, L; Feng, YG; Zhou, ZH, 2013
)
0.39
" Therefore, we performed a meta-analysis to provide an update on the clinical efficacy and safety of tamsulosin combined with SWL for urolithiasis."( The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chen, K; Liu, L; Lv, T; Meng, Q; Mi, H; Sun, X; Wang, S; Xu, G, 2015
)
0.93
"Overall, evidence suggests that tamsulosin combined with SWL is safe and effective in enhancing stone expulsion for patients with urolithiasis."( The Efficacy and Safety of Tamsulosin Combined with Extracorporeal Shockwave Lithotripsy for Urolithiasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chen, K; Liu, L; Lv, T; Meng, Q; Mi, H; Sun, X; Wang, S; Xu, G, 2015
)
1
" Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms."( A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.
Cao, Y; Chen, T; Guo, L; Niu, H; Wang, Y; Yang, X, 2016
)
0.65
"Randomized controlled trials evaluating solifenacin or its combination with tamsulosin for the treatment of SRSs were identified via a comprehensive search of Pubmed, Embase, Ovid, The Cochrane Library and relevant sources up to February 2017."( The role of solifenacin, as monotherapy or combination with tamsulosin in ureteral stent-related symptoms: a systematic review and meta-analysis.
Bai, B; Lei, Y; Mu, J; Wang, J; Zhang, T; Zhang, X, 2017
)
0.93
" The aim of this study was to evaluate a new technology, extracorporeal physical vibrational lithecbole (EPVL) combined with tamsulosin, as a treatment for distal ureteral calculi (DUC)."( Treatment of Distal Ureteral Calculi Using Extracorporeal Physical Vibrational Lithecbole Combined with Tamsulosin: A New Option to Speed Up Obstruction Relief.
Chen, X; Cheng, Y; Hu, J; Jia, X; Liu, G; Wu, W; Xie, G, 2018
)
0.9
"To compare the clinical efficacy differences among acupuncture combined with western medicine, acupuncture alone and western medicine alone for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)."( [Acupuncture combined with western medicine for CP/CPPS:a randomized controlled trial].
Chen, G; Chen, H; Chen, J; Li, T; Ouyang, L; Wang, X; Xiang, J; Zhang, S, 2016
)
0.43
" The patients in the needle-medicine group were treated with acupuncture combined with western medicine; the scalp points included Shenting (GV 24), Xinhui (GV 22), Qianding (GV 21), Baihui (GV 20), Chengguang (BL 6), Tongtian (BL 7), etc."( [Acupuncture combined with western medicine for CP/CPPS:a randomized controlled trial].
Chen, G; Chen, H; Chen, J; Li, T; Ouyang, L; Wang, X; Xiang, J; Zhang, S, 2016
)
0.43
"The efficacy of acupuncture combined with western medicine for CP/CPPS is superior to that of acupuncture alone and western medicine alone, which could improve the symptom of prostatitis as well as status of anxiety and depression."( [Acupuncture combined with western medicine for CP/CPPS:a randomized controlled trial].
Chen, G; Chen, H; Chen, J; Li, T; Ouyang, L; Wang, X; Xiang, J; Zhang, S, 2016
)
0.43
"To evaluate the efficacy and safety of tamsulosin combined with dapoxetine in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that is complicated by premature ejaculation (PE), a total of 251 CP/CPPS patients with PE were recruited from nine hospitals across China and were randomly divided into two groups: one received tamsulosin as a control, and the other received a combination therapy of tamsulosin and dapoxetine."( Beneficial effect of tamsulosin combined with dapoxetine in management of type III prostatitis with premature ejaculation.
Ji, Z; Li, Z; Liang, C; Song, W; Tian, R; Wang, Z; Xia, S; Zhang, L; Zhao, J; Zhao, L, 2019
)
1.1
"Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and erectile dysfunction (ED)."( Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED.
Chapple, C; Gacci, M; Gravas, S; Kaplan, S; McVary, KT; Morselli, S; Sebastianelli, A; Serni, S; Spatafora, P; Vignozzi, L, 2020
)
1.03
"To investigate the clinical effect of pelvic floor muscle rehabilitation training combined with psychological nursing intervention in the treatment of intractable type ⅢB prostatitis."( [Pelvic floor muscle rehabilitation training combined with psychological nursing intervention in the treatment of type ⅢB prostatitis].
Cao, TH; Chen, YF; Ge, YP; Li, GP; Zhang, MX, 2023
)
0.91
"On the basis of Tamsulosin medication, the application of pelvic floor rehabilitation training combined with psychological care can significantly enhance the therapeutic effect on type IIIB prostatitis, effectively relieve prostatitis pain, improve erectile function, lessen anxiety and depression symptoms, increase the level of lecithosomes and promote the recovery of prostatic function."( [Pelvic floor muscle rehabilitation training combined with psychological nursing intervention in the treatment of type ⅢB prostatitis].
Cao, TH; Chen, YF; Ge, YP; Li, GP; Zhang, MX, 2023
)
1.26

Bioavailability

ExcerptReferenceRelevance
" The mean absolute oral bioavailability (+/-SD) was approximated at 100 +/- 19%."( Disposition of the selective alpha1A-adrenoceptor antagonist tamsulosin in humans: comparison with data from interspecies scaling.
Higuchi, S; Matsushima, H; Soeishi, Y; van Hoogdalem, EJ, 1997
)
0.54
" The absolute bioavailability (BA) increased from 19."( Effect of alpha(1)-acid glycoprotein on the pharmacokinetics of tamsulosin in rats treated with turpentine oil.
Higuchi, S; Matsushima, H; Watanabe, T, 2000
)
0.55
" While many of the compounds tested displayed poor pharmacokinetics, compound 48 was found to have adequate bioavailability (>20%) and half-life (>6 h) in both rats and dogs."( In vitro and in vivo evaluation of dihydropyrimidinone C-5 amides as potent and selective alpha(1A) receptor antagonists for the treatment of benign prostatic hyperplasia.
Barrish, A; Barrow, JC; Broten, TP; Chang, RS; Ellis, JD; Forray, C; Freidinger, RM; Gilbert, KF; Glass, KL; Homnick, CF; Kassahun, K; Kling, P; Leppert, P; Nagarathnam, D; Nantermet, PG; O'Malley, SS; Olah, TV; Ransom, RW; Reiss, D; Rittle, KE; Schorn, TW; Selnick, HG; Steele, TG, 2000
)
0.31
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Rapid, simple and highly sensitive LC-ESI-MS/MS method for the quantification of tamsulosin in human plasma.
Koteshwara, M; Manoj, S; Ramakrishna, NV; Varma, DP; Vishwottam, KN; Wishu, S, 2005
)
0.55
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Quantification of pramipexole in human plasma by liquid chromatography tandem mass spectrometry using tamsulosin as internal standard.
Ajjala, D; Kandikere, V; Maurya, S; Mudigonda, K; Nirogi, RV; Shrivastava, W, 2007
)
0.55
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" The oral bioavailability of the MR formulation in the fasted state is close to 100%."( Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral controlled absorption system formulations.
de la Rosette, JJ; Franco-Salinas, G; Michel, MC, 2010
)
0.63
"918) due to the decreased dissolution and absorption rate of the formulation."( Formulation variation and in vitro-in vivo correlation for a rapidly swellable three-layered tablet of tamsulosin HCl.
Choi, YW; Jeong, SH; Kang, JM; Kwon, MC; Lee, MJ; Lee, SH; Park, JS; Shim, JY, 2011
)
0.58
" Our results suggest that MTCR microparticles may be potential oral dosage forms to control the release and to improve the bioavailability of tamsulosin hydrochloride."( Preparation and in vivo evaluation of spray dried matrix type controlled-release microparticles of tamsulosin hydrochloride for orally disintegrating tablet.
Ha, JM; Kim, JY; Oh, TO; Park, CW; Park, ES; Rhee, YS, 2012
)
0.8

Dosage Studied

The study actually assessed unbound tamsulosin concentrations in both blood plasma and prostate tissue. The inhibition was also observed in human liver S9 fractions. Both number of colic episodes and analgesic dosage were significantly lower with tamsilosin.

ExcerptRelevanceReference
" Patient's impression and subjective symptoms were improved in a certain dose-response relationship Side effects were observed in 3 patients but none were serious."( [Clinical efficacy and safety of long-term administration of YM617 for urinary obstruction of the lower urinary tract].
Akino, H; Arai, Y; Fukuyama, T; Hida, S; Okabe, T; Okada, K; Takeuchi, H; Tomoyoshi, T; Yoshida, O, 1991
)
0.28
" In the isolated tissue, pretreatment with CEC (10(-5) M, 10 and 30 min) time-dependently shifted to the right the dose-response curve for phenylephrine and decreased the maximal contraction of aortas induced by phenylephrine, but did not shift or decrease those of prostates."( Alpha 1-adrenoceptor subtype in the rat prostate is preferentially the alpha 1A type.
Honda, K; Yazawa, H, 1993
)
0.29
" Unchanged drug and metabolites in urine and bile were quantified in rat and dog dosed with 14C-TMS(1 mg/kg)."( Metabolism of tamsulosin in rat and dog.
Higuchi, S; Kaniwa, H; Matsushima, H; Soeishi, Y; Teraya, Y; Watanabe, T, 1996
)
0.65
" Plasma and blood radioactivity concentrations attained peak levels (Cmax) within 1 h after dosing and then declined biphasically."( Absorption, metabolism and excretion of tamsulosin hydrochloride in man.
Cornelissen, K; Higuchi, S; Matsushima, H; Soeishi, Y; Ward, J; Watanabe, T, 1996
)
0.56
"4-mg oral dosing was measurable."( Highly sensitive method for the determination of tamsulosin hydrochloride in human plasma dialysate, plasma and urine by high-performance liquid chromatography-electrospray tandem mass spectrometry.
Higuchi, S; Kamimura, H; Matsushima, H; Takanuki, KI; Watanabe, T, 1997
)
0.55
"To evaluate the efficacy and safety in a dose-ranging study of tamsulosin (once-daily) as a modified-release formulation compared with placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO), and to establish the optimum dosage for phase III clinical studies."( A dose-ranging study of the efficacy and safety of tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist, in patients with benign prostatic obstruction (symptomatic benign prostatic hyperplasia).
Abrams, P; Arkell, D; Pocock, R; Speakman, M; Stott, M, 1997
)
0.79
" Another advantage compared with alfuzosin (and prazosin) is the once-daily dosing regimen of tamsulosin."( Comparison of tamsulosin with alfuzosin in the treatment of patients with lower urinary tract symptoms suggestive of bladder outlet obstruction (symptomatic benign prostatic hyperplasia). The European Tamsulosin Study Group.
Buzelin, JM; Fonteyne, E; Khan, A; Kontturi, M; Witjes, WP, 1997
)
0.88
"The pharmacokinetics of tamsulosin hydrochloride, a selective alpha1-adrenoceptor antagonist, was investigated after single iv and oral dosing to rats and dogs, and oral dosing to healthy male volunteers."( Pharmacokinetics and plasma protein binding of tamsulosin hydrochloride in rats, dogs, and humans.
Higuchi, S; Kamimura, H; Matsushima, H; Soeishi, Y; Tsunoo, M; Watanabe, T, 1998
)
0.86
"Once-daily dosing of TAM after breakfast at a fixed dose level (0."( A double-blind comparison of terazosin and tamsulosin on their differential effects on ambulatory blood pressure and nocturnal orthostatic stress testing.
de Mey, C; McEwen, J; Michel, MC; Moreland, T, 1998
)
0.56
" It is a more convenient alternative that does not require initial dosage titration, has a fast onset of action, and has a low potential to cause hypotension when used alone or in combination with commonly used antihypertensive agents."( Tamsulosin for the treatment of benign prostatic hypertrophy.
Lee, M, 2000
)
1.75
"3 mg/kg of TAM was dosed intravenously, total and nonrenal clearances (CL(tot) and CL(nr)) in turpentine-treated rats were 47% and 44% lower than those in nontreated controls, respectively."( Effect of alpha(1)-acid glycoprotein on the pharmacokinetics of tamsulosin in rats treated with turpentine oil.
Higuchi, S; Matsushima, H; Watanabe, T, 2000
)
0.55
"To determine whether the time of dosing (morning or evening) affects the tolerability or efficacy of tamsulosin in the treatment of lower urinary tract symptoms."( Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?
Goepel, M; Mehlburger, L; Michel, MC; Neumann, HG; Schumacher, H, 2001
)
0.75
" The results were analysed statistically for differences between dosing times, using analysis of covariance for the quantitative variables and logistic regression for the qualitative variables."( Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?
Goepel, M; Mehlburger, L; Michel, MC; Neumann, HG; Schumacher, H, 2001
)
0.53
"While no specific recommendation about the dosing time was given in the trial, the retrospective analysis showed that 4420 and 2087 patients received tamsulosin in the morning and evening, respectively."( Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?
Goepel, M; Mehlburger, L; Michel, MC; Neumann, HG; Schumacher, H, 2001
)
0.73
"In contrast to other alpha-blockers, night-time dosing is not necessary to improve the tolerability or efficacy of tamsulosin."( Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?
Goepel, M; Mehlburger, L; Michel, MC; Neumann, HG; Schumacher, H, 2001
)
0.74
" The inhibition peaked about 90 min after dosing and lasted up to 240 min."( Pharmacological effect of tamsulosin in relation to dog plasma and tissue concentrations: prostatic and urethral retention possibly contributes to uroselectivity of tamsulosin.
Matsushima, H; Miyata, K; Ohtake, A; Saitoh, C; Sato, S; Usuda, S, 2001
)
0.61
"8 mg daily had a rapid onset of action and was effective and well tolerated, with minimal differences observed between dosage groups."( A comparison of two phase III multicenter, placebo-controlled studies of tamsulosin in BPH.
Bruskewitz, R; Narayan, P,
)
0.36
" Plasma tamsulosin concentrations were measured at regular intervals after dosing on day 15."( Effects of the concomitant administration of tamsulosin (0.8 mg) on the pharmacokinetic and safety profile of intravenous digoxin (Lanoxin) in normal healthy subjects: a placebo-controlled evaluation.
Forrest, A; Ito, Y; Kamimura, H; Miyazawa, Y; Paul Starkey, L; Schentag, JJ; Swarz, H, 2002
)
1.01
"2 mg dosage was given daily, and uroflowmetry was followed."( [Tamsulosin for the treatment of chronic abacterial prostatitis].
Chen, XS; Ye, ZQ; Zeng, XY, 2002
)
1.22
" Mean sodium diclofenac dosage per patient in groups 1 to 3 was 19."( Nifedipine versus tamsulosin for the management of lower ureteral stones.
Fiori, C; Fontana, D; Ghignone, G; Porpiglia, F; Scarpa, RM, 2004
)
0.66
" He had been administered distigmine bromide orally for over two years at a daily dosage of 10 mg as a treatment for underactive neurogenic bladder."( [A case of acute distigmine bromide intoxication in the therapeutic dosage for treatment of underactive neurogenic bladder].
Fujita, N; Koike, H; Nagai, H; Tada, M; Umeda, M, 2004
)
0.32
" Higher rates of twice-daily (or 2 units per day) dosing are associated with higher incremental cost-effectiveness ratios."( Cost-effectiveness of tamsulosin, doxazosin, and terazosin in the treatment of benign prostatic hyperplasia.
Chrischilles, EA; Klein, RW; Kreder, KJ; Ohsfeldt, RL,
)
0.45
" Blood pressure (BP) and heart rate were recorded before dosing and for 24 hours after dosing."( Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy normotensive men.
Bedding, A; Emmick, JT; Jackson, G; Kloner, RA; Mitchell, MI; Pereira, A; Warner, MR, 2004
)
0.54
" Meanwhile the number of pain episodes, analgesic dosage and the number of days for spontaneous passage of the calculi through the ureter were also recorded."( The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones.
Basar, H; Basar, MM; Batislam, E; Ferhat, M; Tuglu, D; Yilmaz, E, 2005
)
0.33
" In study 1, CV alpha1-adrenoceptor antagonism was assessed by measuring the inhibition of phenylephrine (PE)-induced increases in diastolic blood pressure (DBP) and total peripheral resistance (TPR) before and after dosing with placebo, tamsulosin OCAS, and alfuzosin XL in 18 young subjects."( Comparison of the cardiovascular effects of tamsulosin oral controlled absorption system (OCAS) and alfuzosin prolonged release (XL).
Chapple, CR; Michel, MC, 2006
)
0.78
"In study 1, tamsulosin OCAS induced statistically significantly less inhibition of PE-induced increases in DBP at 2 h after dosing and in TPR at 2 and 4 h after dosing than alfuzosin XL."( Comparison of the cardiovascular effects of tamsulosin oral controlled absorption system (OCAS) and alfuzosin prolonged release (XL).
Chapple, CR; Michel, MC, 2006
)
0.97
" In conclusion, the prediction of alpha(1)-adrenoceptor occupancy in the human prostate by alpha(1)-adrenoceptor antagonists may provide the rationale for the optimum dosage regimen of these drugs in the therapy of BPH."( Prediction of alpha1-adrenoceptor occupancy in the human prostate from plasma concentrations of silodosin, tamsulosin and terazosin to treat urinary obstruction in benign prostatic hyperplasia.
Kagawa, Y; Kato, Y; Kawabe, K; Okura, T; Yamada, S, 2007
)
0.55
"To evaluate the efficacy of tamsulosin oral-controlled absorption system (OCAS) vs placebo in overactive bladder (OAB), to evaluate the safety and tolerability of once-daily dosing with tamsulosin OCAS, and to compare the efficacy and safety with tolterodine extended-release (ER)."( A randomized double-blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome.
Bolodeoku, J; Cardozo, L; Robinson, D; Terpstra, G, 2007
)
0.85
" The incidence of hypotension was low in healthy men given increasing doses of doxazosin with chronically dosed tadalafil or placebo."( Hemodynamic interaction between a daily dosed phosphodiesterase 5 inhibitor, tadalafil, and the alpha-adrenergic blockers, doxazosin and tamsulosin, in middle-aged healthy male subjects.
Darstein, C; Guillaume, M; Jimenez, MC; Lonsdale, F; Mitchell, MI, 2007
)
0.54
"After the dosage form of tamsulosin hydrochloride was changed from a capsule to on orally disintegrating tablet (ODT, Harnal D), we often received patient complaints and noted an increase in noncompliance with medication regimens."( [Some problems for dosage form based on questionnaire surveying compliance in patients taking tamsulosin hydrochloride].
Hirayama, H; Ishimatsu, T; Ogata, I; Seo, H; Tsuruda, A; Tsuzaki, S; Yamasaki, K, 2008
)
0.87
" Mean analgesic dosage per patient in groups 1, 2, and 3 were 231, 256, and 347 mg, respectively."( Efficacy of an alpha1 blocker in expulsive therapy of lower ureteral stones.
Chang, CH; Huang, SW; Wang, CJ, 2008
)
0.35
" Reports of pain and supplemental analgesic dosing were consistently lower with tamsulosin, but data on the incidence of subsequent retreatment with ESWL or ureteroscopy was rarely reported."( Efficacy of tamsulosin with extracorporeal shock wave lithotripsy for passage of renal and ureteral calculi.
Losek, RL; Mauro, LS, 2008
)
0.95
" This result suggests that blending these two-part pellets (SR and ER) can provide an alternative to preparing a controlled-release dosage form, instead of blending of the coating polymer."( Development of a tamsulosin hydrochloride controlled-release capsule consisting of two different coated pellets.
Tang, X; Yang, R; Zhang, X, 2009
)
0.69
" The inhibition was also observed in human liver S9 fractions, suggesting that a reassessment of the oral dosage of tamsulosin is necessary when udenafil and tamsulosin are co-administered to patients with benign prostatic hyperplasia."( Interaction between udenafil and tamsulosin in rats: non-competitive inhibition of tamsulosin metabolism by udenafil via hepatic CYP3A1/2.
Bae, SK; Kang, HE; Kim, YG; Lee, DC; Lee, MG; Yoo, M, 2009
)
0.84
" The number of colic episodes, lower urinary tract symptoms, analgesic dosage and days for spontaneous passage of the stones through the ureter were recorded by diary."( Adjunctive medical therapy with an alpha-1A-specific blocker after shock wave lithotripsy of lower ureteral stones.
Chang, CH; Huang, SW; Wang, CJ, 2009
)
0.35
"Administration of an alpha-1A-specific blocker reduced analgesic dosage and colic episodes after SWL of lower ureteral stones."( Adjunctive medical therapy with an alpha-1A-specific blocker after shock wave lithotripsy of lower ureteral stones.
Chang, CH; Huang, SW; Wang, CJ, 2009
)
0.35
" Moreover, the frequency of pain episodes, the need for diclofenac, and its total dosage were significantly lower in the tamsulosin group."( Efficacy of tamsulosin in the management of lower ureteral stones: a randomized double-blind placebo-controlled study of 100 patients.
Al-Ansari, A; Al-Naimi, A; Alobaidy, A; Assadiq, K; Azmi, MD; Shokeir, AA, 2010
)
0.95
"Patients' records were reviewed, and age, medical, surgical, and ocular history; gender; medications; and duration and dosage of tamsulosin were recorded."( The effect of alpha1-adrenergic receptor antagonist tamsulosin (Flomax) on iris dilator smooth muscle anatomy.
Chang, DF; Destafeno, JJ; Kim, T; Proia, AD; Santaella, RM; Stinnett, SS, 2010
)
0.82
" Pain episodes, day of spontaneous stone expulsion, total analgesic dosage and drug side-effects were recorded."( Tamsulosin as an expulsive therapy for steinstrasse after extracorporeal shock wave lithotripsy: a randomized controlled study.
Abuzeid, A; Gamal, WM; Moursy, E, 2010
)
1.8
"Reversed-phase high-performance liquid chromatography (RP-HPLC) and thin-layer chromatography (TLC) methods have been developed and validated for simultaneous estimation of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms."( Validated RP-HPLC and TLC methods for simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage forms.
Patel, DB; Patel, NJ, 2010
)
0.79
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
"The study actually assessed unbound tamsulosin concentrations in both blood plasma and prostate tissue and reported that the unbound tamsulosin concentrations after multiple dosing in men with BPH, were much higher in prostate than in blood plasma."( Tamsulosin shows a higher unbound drug fraction in human prostate than in plasma: a basis for uroselectivity?
Korstanje, C; Krauwinkel, W; van Doesum-Wolters, FL, 2011
)
2.09
" Both number of colic episodes and analgesic dosage were significantly lower with tamsulosin as compared to control and doxazosin."( Tamsulosin and doxazosin as adjunctive therapy following shock-wave lithotripsy of renal calculi: randomized controlled trial.
Fareed, K; Fouda, K; Gaafar, S; Marzouk, E; Yakoubi, R; Zahran, AR; Zaytoun, OM, 2012
)
2.05
" Our results suggest that MTCR microparticles may be potential oral dosage forms to control the release and to improve the bioavailability of tamsulosin hydrochloride."( Preparation and in vivo evaluation of spray dried matrix type controlled-release microparticles of tamsulosin hydrochloride for orally disintegrating tablet.
Ha, JM; Kim, JY; Oh, TO; Park, CW; Park, ES; Rhee, YS, 2012
)
0.8
" Comparison of DR(10) values (the dose required to shift the dose-response curve 10-fold to the right) in both tissues showed that the inhibitory effect of silodosin was significantly more potent in the salivary gland than in the urethra (18-fold), but tamsulosin (2."( Effects of α1-adrenoceptor antagonists on phenylephrine-induced salivary secretion and intraurethral pressure elevation in anesthetized rats.
Hatanaka, T; Noguchi, Y; Ohtake, A; Sasamata, M; Sato, S; Suzuki, M; Ueshima, K; Yanai-Inamura, H, 2012
)
0.56
"05 for the dose-response slope, all variables)."( Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).
Angulo, JC; Garcia-Hernandez, A; Haab, F; Katona, F; Klaver, M; Oelke, M; Traudtner, K; Van Kerrebroeck, P; Vik, V, 2013
)
0.66
"To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms."( Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.
Chapple, C; Drake, MJ; Drogendijk, T; Klaver, M; Oelke, M; Sokol, R; Traudtner, K; Van Kerrebroeck, P, 2015
)
0.64
" Blood samples were collected up to 48 hours after dosing on study day 1 and up to 24 hours after dosing on study day 9 for determination of plasma concentrations with a validated LC-MS/MS method."( Pharmacokinetic interaction of finasteride with tamsulosin hydrochloride: an open-label, randomized, 3-period crossover study in healthy Chinese male volunteers.
Chen, W; Chu, N; Li, X; Wang, G; Wang, J; Xu, H; Yang, M; Yuan, F, 2015
)
0.67
"Daily tamsulosin therapy does not enhance the clearance of stone fragments but decreases the pain episodes, analgesia dosage and need for adjuvant intervention after SWL for renal stones."( Role of Tamsulosin Therapy after Extracorporeal Shockwave Lithotripsy for Renal Stones: Randomized Controlled Trial.
Ahmed, AF; El-Feky, M; El-Kholy, M; Elsotohi, E; Kotb, A; Ragab, A; Salem, E; Shalaby, E, 2016
)
1.35
"This research aims to evaluate the role of tamsulosin in the medical expulsion therapy for distal ureteral stones, including her effects in stone expulsion time, expulsion rates, stone size, pain episodes and analgesic dosage usage."( The Role of the Tamsulosin in the Medical Expulsion Therapy for Distal Ureteral Stones.
Hyseni, N; Nuraj, P, 2017
)
1.06
"A validated and selective high-performance thin-layer chromatography (HPTLC) method was developed for the analysis of mixures of tamsulosin hydrochloride (TAM) with either tolterodine tartrate (TOL) or solifenacin succinate (SOL) in bulk drug and in combined dosage forms."( Novel Validated HPTLC Method for the Analysis of Two Binary Mixtures Containing Tamsulosin Hydrochloride with Antimuscarinic Agents.
Abdel Moneim, MM; Belal, SF; El-Kimary, EI; Khamis, EF, 2018
)
0.91
"The combination of solifenacin in a double dosage along with tamsulosin can be recommended for elderly benign prostatic hyperplasia patients with overactive bladder symptoms."( Cognitive functions and health-related quality of life in men with benign prostatic hyperplasia and symptoms of overactive bladder when treated with a combination of tamsulosin and solifenacin in a higher dosage.
Gainullina, Y; Kosilov, K; Kosilova, L; Kuzina, I; Kuznetsov, V; Loparev, S; Prokofyeva, A, 2018
)
0.92
" The developed method was successfully applied to determine the studied drugs in dosage forms and human plasma samples and the results were satisfactory as revealed by statistical analysis of the data."( Simultaneous HPLC determination of alfuzosin, tamsulosin and vardenafil in human plasma and pharmaceutical formulations using time programmed fluorescence detection.
Belal, F; Borg, H; Fathy, M; Walash, MI; Zayed, S, 2019
)
0.77
" Furthermore, the methods were successfully applied for the quantification of the two drugs in their combined dosage form."( Smart spectrophotometric assessment of tamsulosin hydrochloride and tadalafil in their new pharmaceutical formulation for treatment of benign prostatic hyperplasia and erectile dysfunction.
Rezk, MR; Tantawy, MA; Wadie, M; Weshahy, SA, 2020
)
0.83
" Additional dose-response analyses were carried out."( Association of Glycolysis-Enhancing α-1 Blockers With Risk of Developing Parkinson Disease.
Liu, L; Narayanan, NS; Pottegård, A; Simmering, JE; Welsh, MJ, 2021
)
0.62
" This study is the first to develop and optimize a synchronous spectrofluorimetric method coupled with derivative and derivative ratio mathematical tools for the determination of tamsulosin andtadalafil in their newly released dosage form."( Assay of new combination of tamsulosin and tadalafil using synchronous spectrofluorimetric method coupled with mathematical tools.
Abdelhafez, AM; Gawad, DA; Hassan, EM; M Youssef, R, 2022
)
1.21
" Dose-response analysis using defined daily doses of drug (DDDs) was conducted."( Use of α1-adrenoceptor antagonists tamsulosin and alfuzosin and the risk of Alzheimer's disease.
Hartikainen, S; Latvala, L; Murtola, TJ; Tiihonen, M; Tolppanen, AM, 2022
)
1
" However, very few studies were reported for their simultaneous quantification in their combined dosage form and were mainly based on chromatographic analysis."( A New Chemometrically Assisted UV Spectrophotometric Method for Simultaneous Determination of Tamsulosin and Dutasteride in Their Pharmaceutical Mixture.
Abbas, AEF; Attia, KAM; Eid, SM; Serag, A, 2022
)
0.94
"The proposed models were effectively used to determine TAM/DUT in their combined dosage form, and statistical comparison with the reported method revealed satisfactory results."( A New Chemometrically Assisted UV Spectrophotometric Method for Simultaneous Determination of Tamsulosin and Dutasteride in Their Pharmaceutical Mixture.
Abbas, AEF; Attia, KAM; Eid, SM; Serag, A, 2022
)
0.94
"Overall, this work presents powerful simple, selective, sensitive, and precise methods for simultaneous quantification of TAM/DUT in their dosage form with satisfactory results."( A New Chemometrically Assisted UV Spectrophotometric Method for Simultaneous Determination of Tamsulosin and Dutasteride in Their Pharmaceutical Mixture.
Abbas, AEF; Attia, KAM; Eid, SM; Serag, A, 2022
)
0.94
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
alpha-adrenergic antagonistAn agent that binds to but does not activate alpha-adrenergic receptors thereby blocking the actions of endogenous or exogenous alpha-adrenergic agonists. alpha-Adrenergic antagonists are used in the treatment of hypertension, vasospasm, peripheral vascular disease, shock, and pheochromocytoma.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
5-(2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl)-2-methoxybenzenesulfonamideA secondary amino compound that is ammonia in which nitrogen is substituted by a 1-(4-methoxy-3-sulfamoylphenyl)propan-2-yl group and a 2-(2-ethoxyphenoxy)ethyl group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (23)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency36.12540.005612.367736.1254AID624032
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Alpha-1A adrenergic receptorOryctolagus cuniculus (rabbit)Ki0.00210.00000.02040.2512AID36753
5-hydroxytryptamine receptor 1AHomo sapiens (human)Ki0.00080.00010.532610.0000AID3814
Alpha-2A adrenergic receptorHomo sapiens (human)Ki0.03820.00010.807410.0000AID35936; AID35938
Tryptophan 5-hydroxylase 1Rattus norvegicus (Norway rat)Ki0.01300.00050.09140.4900AID64468
D(2) dopamine receptorHomo sapiens (human)Ki0.04550.00000.651810.0000AID64468; AID64664
Alpha-1A adrenergic receptorBos taurus (cattle)Ki0.00010.00000.50723.7020AID36466
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.00790.00030.483410.0000AID36397
Alpha-1B adrenergic receptorMesocricetus auratus (golden hamster)Ki0.00020.00002.01679.6000AID32974
Alpha-2B adrenergic receptorRattus norvegicus (Norway rat)Ki0.04340.00000.929610.0000AID36252; AID36371
Alpha-1D adrenergic receptorRattus norvegicus (Norway rat)Ki0.00010.00000.575110.0000AID32975
Sodium-dependent dopamine transporterRattus norvegicus (Norway rat)Ki0.07800.00030.37088.1600AID64664
Alpha-1D adrenergic receptorHomo sapiens (human)IC50 (µMol)0.00080.00020.75688.8970AID1320516; AID1743296
Alpha-1D adrenergic receptorHomo sapiens (human)Ki0.00210.00000.360910.0000AID1296472; AID290868; AID296252; AID321752; AID35303; AID35309; AID35468; AID36252; AID545213
5-hydroxytryptamine receptor 7Homo sapiens (human)Ki0.08400.00030.380610.0000AID6590
Alpha-1A adrenergic receptorHomo sapiens (human)IC50 (µMol)0.00130.00020.56145.4000AID1320512; AID1743294
Alpha-1A adrenergic receptorHomo sapiens (human)Ki0.00170.00000.272610.0000AID290866; AID296250; AID321750; AID36252; AID36466; AID36478; AID36483; AID36753; AID545211
Alpha-1B adrenergic receptorHomo sapiens (human)IC50 (µMol)0.00450.00020.65268.3300AID1320515; AID1743295
Alpha-1B adrenergic receptorHomo sapiens (human)Ki0.01240.00000.471310.0000AID290867; AID296251; AID321751; AID36252; AID37200; AID37205; AID37478; AID545212
D(3) dopamine receptorHomo sapiens (human)Ki0.00030.00000.602010.0000AID65117
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)Ki0.00010.00000.965010.0000AID32968; AID545211; AID692053
Alpha-1D adrenergic receptorMus musculus (house mouse)IC50 (µMol)0.00180.00180.00180.0018AID1491368
Alpha-1B adrenergic receptorMus musculus (house mouse)IC50 (µMol)0.00180.00180.00180.0018AID1491368
Alpha-1A adrenergic receptorMus musculus (house mouse)IC50 (µMol)0.00180.00180.00180.0018AID1491368
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Alpha-1A adrenergic receptorOryctolagus cuniculus (rabbit)Kd0.00020.00020.01430.0501AID37056
Alpha-2B adrenergic receptorRattus norvegicus (Norway rat)Kd0.00020.00020.62779.3325AID37056
Alpha-2C adrenergic receptorRattus norvegicus (Norway rat)Kd0.00020.00020.62779.3325AID37056
Alpha-2A adrenergic receptorRattus norvegicus (Norway rat)Kd0.00020.00020.62779.3325AID37056
Alpha-1D adrenergic receptorHomo sapiens (human)Kd0.00000.00000.19451.2882AID36126
Alpha-1A adrenergic receptorHomo sapiens (human)EC50 (µMol)0.00010.00010.50987.1000AID1323687
Alpha-1A adrenergic receptorHomo sapiens (human)Kd0.00000.00000.20481.2882AID36126
Alpha-1B adrenergic receptorHomo sapiens (human)EC50 (µMol)0.00010.00011.30105.6000AID1323689
Alpha-1B adrenergic receptorHomo sapiens (human)Kd0.00010.00000.11991.2882AID36126; AID37056
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (193)

Processvia Protein(s)Taxonomy
behavioral fear response5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
adenylate cyclase-inhibiting serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
gamma-aminobutyric acid signaling pathway5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of serotonin secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of vasoconstriction5-hydroxytryptamine receptor 1AHomo sapiens (human)
exploration behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of dopamine metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin metabolic process5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of hormone secretion5-hydroxytryptamine receptor 1AHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 1AHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 1AHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 1AHomo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
temperature homeostasisD(2) dopamine receptorHomo sapiens (human)
response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein phosphorylationD(2) dopamine receptorHomo sapiens (human)
response to amphetamineD(2) dopamine receptorHomo sapiens (human)
nervous system process involved in regulation of systemic arterial blood pressureD(2) dopamine receptorHomo sapiens (human)
regulation of heart rateD(2) dopamine receptorHomo sapiens (human)
regulation of sodium ion transportD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(2) dopamine receptorHomo sapiens (human)
positive regulation of neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
positive regulation of receptor internalizationD(2) dopamine receptorHomo sapiens (human)
autophagyD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
neuron-neuron synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
neuroblast proliferationD(2) dopamine receptorHomo sapiens (human)
axonogenesisD(2) dopamine receptorHomo sapiens (human)
synapse assemblyD(2) dopamine receptorHomo sapiens (human)
sensory perception of smellD(2) dopamine receptorHomo sapiens (human)
long-term memoryD(2) dopamine receptorHomo sapiens (human)
grooming behaviorD(2) dopamine receptorHomo sapiens (human)
locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
adult walking behaviorD(2) dopamine receptorHomo sapiens (human)
protein localizationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell population proliferationD(2) dopamine receptorHomo sapiens (human)
associative learningD(2) dopamine receptorHomo sapiens (human)
visual learningD(2) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(2) dopamine receptorHomo sapiens (human)
response to light stimulusD(2) dopamine receptorHomo sapiens (human)
response to toxic substanceD(2) dopamine receptorHomo sapiens (human)
response to iron ionD(2) dopamine receptorHomo sapiens (human)
response to inactivityD(2) dopamine receptorHomo sapiens (human)
Wnt signaling pathwayD(2) dopamine receptorHomo sapiens (human)
striatum developmentD(2) dopamine receptorHomo sapiens (human)
orbitofrontal cortex developmentD(2) dopamine receptorHomo sapiens (human)
cerebral cortex GABAergic interneuron migrationD(2) dopamine receptorHomo sapiens (human)
adenohypophysis developmentD(2) dopamine receptorHomo sapiens (human)
negative regulation of cell migrationD(2) dopamine receptorHomo sapiens (human)
peristalsisD(2) dopamine receptorHomo sapiens (human)
auditory behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of synaptic transmission, GABAergicD(2) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(2) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
response to histamineD(2) dopamine receptorHomo sapiens (human)
response to nicotineD(2) dopamine receptorHomo sapiens (human)
positive regulation of urine volumeD(2) dopamine receptorHomo sapiens (human)
positive regulation of renal sodium excretionD(2) dopamine receptorHomo sapiens (human)
positive regulation of multicellular organism growthD(2) dopamine receptorHomo sapiens (human)
response to cocaineD(2) dopamine receptorHomo sapiens (human)
negative regulation of circadian sleep/wake cycle, sleepD(2) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(2) dopamine receptorHomo sapiens (human)
drinking behaviorD(2) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(2) dopamine receptorHomo sapiens (human)
response to morphineD(2) dopamine receptorHomo sapiens (human)
pigmentationD(2) dopamine receptorHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
positive regulation of G protein-coupled receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(2) dopamine receptorHomo sapiens (human)
negative regulation of innate immune responseD(2) dopamine receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IID(2) dopamine receptorHomo sapiens (human)
negative regulation of insulin secretionD(2) dopamine receptorHomo sapiens (human)
acid secretionD(2) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(2) dopamine receptorHomo sapiens (human)
behavioral response to ethanolD(2) dopamine receptorHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityD(2) dopamine receptorHomo sapiens (human)
response to axon injuryD(2) dopamine receptorHomo sapiens (human)
branching morphogenesis of a nerveD(2) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(2) dopamine receptorHomo sapiens (human)
epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationD(2) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(2) dopamine receptorHomo sapiens (human)
release of sequestered calcium ion into cytosolD(2) dopamine receptorHomo sapiens (human)
dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
positive regulation of dopamine uptake involved in synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
regulation of synapse structural plasticityD(2) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(2) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(2) dopamine receptorHomo sapiens (human)
excitatory postsynaptic potentialD(2) dopamine receptorHomo sapiens (human)
positive regulation of growth hormone secretionD(2) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(2) dopamine receptorHomo sapiens (human)
negative regulation of dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeD(2) dopamine receptorHomo sapiens (human)
regulation of locomotion involved in locomotory behaviorD(2) dopamine receptorHomo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionD(2) dopamine receptorHomo sapiens (human)
negative regulation of cellular response to hypoxiaD(2) dopamine receptorHomo sapiens (human)
positive regulation of glial cell-derived neurotrophic factor productionD(2) dopamine receptorHomo sapiens (human)
positive regulation of long-term synaptic potentiationD(2) dopamine receptorHomo sapiens (human)
hyaloid vascular plexus regressionD(2) dopamine receptorHomo sapiens (human)
negative regulation of neuron migrationD(2) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(2) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(2) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(2) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(2) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(2) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(2) dopamine receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-1A adrenergic receptorBos taurus (cattle)
positive regulation of MAPK cascadeAlpha-1A adrenergic receptorBos taurus (cattle)
regulation of cardiac muscle contractionAlpha-1A adrenergic receptorBos taurus (cattle)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-1D adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1D adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1D adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1D adrenergic receptorHomo sapiens (human)
smooth muscle contraction5-hydroxytryptamine receptor 7Homo sapiens (human)
circadian rhythm5-hydroxytryptamine receptor 7Homo sapiens (human)
blood circulation5-hydroxytryptamine receptor 7Homo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 7Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 7Homo sapiens (human)
MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of heart rate involved in baroreceptor response to increased systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine vasoconstriction involved in regulation of systemic arterial blood pressureAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of heart rate by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of the force of heart contraction by epinephrine-norepinephrineAlpha-1A adrenergic receptorHomo sapiens (human)
apoptotic processAlpha-1A adrenergic receptorHomo sapiens (human)
smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
activation of phospholipase C activityAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1A adrenergic receptorHomo sapiens (human)
adult heart developmentAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of cell population proliferationAlpha-1A adrenergic receptorHomo sapiens (human)
response to xenobiotic stimulusAlpha-1A adrenergic receptorHomo sapiens (human)
response to hormoneAlpha-1A adrenergic receptorHomo sapiens (human)
negative regulation of autophagyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle hypertrophyAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of synaptic transmission, GABAergicAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of action potentialAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of vasoconstrictionAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of smooth muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
calcium ion transport into cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of cardiac muscle contractionAlpha-1A adrenergic receptorHomo sapiens (human)
cell growth involved in cardiac muscle cell developmentAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAlpha-1A adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase C signalingAlpha-1A adrenergic receptorHomo sapiens (human)
pilomotor reflexAlpha-1A adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1A adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-1B adrenergic receptorHomo sapiens (human)
intracellular signal transductionAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-1B adrenergic receptorHomo sapiens (human)
regulation of cardiac muscle contractionAlpha-1B adrenergic receptorHomo sapiens (human)
neuron-glial cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-1B adrenergic receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayAlpha-1B adrenergic receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationAlpha-1B adrenergic receptorHomo sapiens (human)
response to ethanolD(3) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(3) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
learning or memoryD(3) dopamine receptorHomo sapiens (human)
learningD(3) dopamine receptorHomo sapiens (human)
locomotory behaviorD(3) dopamine receptorHomo sapiens (human)
visual learningD(3) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(3) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(3) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(3) dopamine receptorHomo sapiens (human)
response to histamineD(3) dopamine receptorHomo sapiens (human)
social behaviorD(3) dopamine receptorHomo sapiens (human)
response to cocaineD(3) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(3) dopamine receptorHomo sapiens (human)
response to morphineD(3) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(3) dopamine receptorHomo sapiens (human)
positive regulation of mitotic nuclear divisionD(3) dopamine receptorHomo sapiens (human)
acid secretionD(3) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(3) dopamine receptorHomo sapiens (human)
negative regulation of oligodendrocyte differentiationD(3) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(3) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(3) dopamine receptorHomo sapiens (human)
musculoskeletal movement, spinal reflex actionD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(3) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(3) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(3) dopamine receptorHomo sapiens (human)
positive regulation of dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(3) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(3) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(3) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(3) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(3) dopamine receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (25)

Processvia Protein(s)Taxonomy
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
receptor-receptor interaction5-hydroxytryptamine receptor 1AHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 1AHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 1AHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(2) dopamine receptorHomo sapiens (human)
G-protein alpha-subunit bindingD(2) dopamine receptorHomo sapiens (human)
protein bindingD(2) dopamine receptorHomo sapiens (human)
heterotrimeric G-protein bindingD(2) dopamine receptorHomo sapiens (human)
dopamine bindingD(2) dopamine receptorHomo sapiens (human)
ionotropic glutamate receptor bindingD(2) dopamine receptorHomo sapiens (human)
identical protein bindingD(2) dopamine receptorHomo sapiens (human)
heterocyclic compound bindingD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(2) dopamine receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1A adrenergic receptorBos taurus (cattle)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
identical protein bindingAlpha-1D adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1D adrenergic receptorHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 7Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 7Homo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-1B adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-1B adrenergic receptorHomo sapiens (human)
alpha1-adrenergic receptor activityAlpha-1B adrenergic receptorHomo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(3) dopamine receptorHomo sapiens (human)
protein bindingD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(3) dopamine receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (36)

Processvia Protein(s)Taxonomy
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
synapse5-hydroxytryptamine receptor 1AHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 1AHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 1AHomo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
Golgi membraneD(2) dopamine receptorHomo sapiens (human)
acrosomal vesicleD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
ciliumD(2) dopamine receptorHomo sapiens (human)
lateral plasma membraneD(2) dopamine receptorHomo sapiens (human)
endocytic vesicleD(2) dopamine receptorHomo sapiens (human)
axonD(2) dopamine receptorHomo sapiens (human)
dendriteD(2) dopamine receptorHomo sapiens (human)
synaptic vesicle membraneD(2) dopamine receptorHomo sapiens (human)
sperm flagellumD(2) dopamine receptorHomo sapiens (human)
dendritic spineD(2) dopamine receptorHomo sapiens (human)
perikaryonD(2) dopamine receptorHomo sapiens (human)
axon terminusD(2) dopamine receptorHomo sapiens (human)
postsynaptic membraneD(2) dopamine receptorHomo sapiens (human)
ciliary membraneD(2) dopamine receptorHomo sapiens (human)
non-motile ciliumD(2) dopamine receptorHomo sapiens (human)
dopaminergic synapseD(2) dopamine receptorHomo sapiens (human)
GABA-ergic synapseD(2) dopamine receptorHomo sapiens (human)
G protein-coupled receptor complexD(2) dopamine receptorHomo sapiens (human)
glutamatergic synapseD(2) dopamine receptorHomo sapiens (human)
presynaptic membraneD(2) dopamine receptorHomo sapiens (human)
plasma membraneD(2) dopamine receptorHomo sapiens (human)
nucleusAlpha-1A adrenergic receptorBos taurus (cattle)
cytoplasmAlpha-1A adrenergic receptorBos taurus (cattle)
plasma membraneAlpha-1A adrenergic receptorBos taurus (cattle)
caveolaAlpha-1A adrenergic receptorBos taurus (cattle)
nuclear membraneAlpha-1A adrenergic receptorBos taurus (cattle)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1D adrenergic receptorHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
trans-Golgi network membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
synapse5-hydroxytryptamine receptor 7Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 7Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 7Homo sapiens (human)
nucleusAlpha-1A adrenergic receptorHomo sapiens (human)
nucleoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1A adrenergic receptorHomo sapiens (human)
cytosolAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
caveolaAlpha-1A adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1A adrenergic receptorHomo sapiens (human)
intracellular membrane-bounded organelleAlpha-1A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1A adrenergic receptorHomo sapiens (human)
nucleusAlpha-1B adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
caveolaAlpha-1B adrenergic receptorHomo sapiens (human)
nuclear membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-1B adrenergic receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
synapseD(3) dopamine receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (185)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID545218Antagonist activity at Alpha-1B adrenoceptor in Wistar rat spleen assessed as phenylephrine induced contractions after 30 mins2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID1320515Antagonist activity at human full-length N-terminal SNAP-tagged alpha1B adrenoceptor expressed in HEK293 cells assessed as inhibition of agonist-induced calcium mobilization preincubated for 10 mins followed by agonist addition by fluo-4 AM dye-based assa2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID1323689Intrinsic activity at human alpha1B adrenergic receptor expressed in CHOK1 cells co-expressing aequorin assessed as inhibition of agonist induced calcium mobilization preincubated for 15 mins followed by agonist addition measured for 20 secs in presence o2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1491368Displacement of [3H]prazosin from alpha1 adrenoceptor in C57BL/6 mouse hippocampal homogenates after 40 mins by liquid scintillation counting method2017European journal of medicinal chemistry, Sep-08, Volume: 137Evaluation of the antidepressant therapeutic potential of isocyanine and pseudoisocyanine analogues of the organic cation decynium-22.
AID545217Antagonist activity at alpha1A adrenoceptor in Wistar rat vas deferens assessed as noradrenaline induced contractions after 30 mins2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID545224Selectivity ratio of EC50 for alpha1A adrenoceptor in Wistar rat vas deferens to EC50 for Alpha-1D adrenoceptor in Wistar rat thoracic aorta2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID545214Selectivity ratio of Ki for human alpha1A adrenoceptor to Ki for human Alpha-1B adrenoceptor2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID1320513Antagonist activity at human full-length N-terminal SNAP-tagged alpha1A adrenoceptor expressed in HEK293 cells assessed as inhibition of agonist-induced calcium mobilization at 10 uM preincubated for 10 mins followed by agonist addition by fluo-4 AM dye-b2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID232245Selectivity ratio (antolog[pA2 of IUP-pED50 of SHR]) of the compound2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID35468Binding affinity was tested on human Alpha-1D adrenergic receptor1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID229425Selectivity ratio against D2L (dopaminergic) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID230343Ratio of rat prostate KB to rat aorta KB2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID229427Selectivity ratio against D3 (dopaminergic) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID35155In vitro antagonistic activity against alpha-1B receptor in rat spleen.2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID36126Activity against Alpha-1 adrenergic receptor subtypes of human prostate tissue1997Journal of medicinal chemistry, Aug-15, Volume: 40, Issue:17
N-arylpiperazinyl-N'-propylamino derivatives of heteroaryl amides as functional uroselective alpha 1-adrenoceptor antagonists.
AID229429Selectivity ratio against alpha-2B (Adrenergic Receptor-2B) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID692053Displacement of [3H]prazosin from rat salivary gland adrenergic alpha 1A receptor after 45 mins by liquid scintillation counter2011European journal of medicinal chemistry, Jul, Volume: 46, Issue:7
Discovery of LASSBio-772, a 1,3-benzodioxole N-phenylpiperazine derivative with potent alpha 1A/D-adrenergic receptor blocking properties.
AID3675Compound at 1 uM was tested for the inhibition of radioligand [3H]5-HT binding to 5-hydroxytryptamine 1 receptor in rat cerebral cortex2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID229435Selectivity ratio against phenylalkylamine-sensitive [Ca2+] L channels2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID224635Dose required to inhibit the prostate contractile response by 50% after challenge with selective alpha-1a agonist A61603 and duration of action was 3.5h in an in situ rat prostate model2000Bioorganic & medicinal chemistry letters, Aug-07, Volume: 10, Issue:15
Selective alpha1a adrenergic receptor antagonists based on 4-aryl-3,4-dihydropyridine-2-ones.
AID3782Compound at 1 uM was tested for the inhibition of radioligand [3H]8-OH-DPAT binding to recombinant human 5-hydroxytryptamine 1A receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID1743295Antagonist activity at human alpha1B receptor transfected in HEK293 cells co-transfected with Galpha16 assessed as reduction in intracellular calcium release incubated for 40 mins by Fluo-4AM dye based fluorescence assay2020European journal of medicinal chemistry, Nov-01, Volume: 205The one-pot synthesis of butyl-1H-indol-3-alkylcarboxylic acid derivatives in ionic liquid as potent dual-acting agent for management of BPH.
AID1323698Hypotensive activity in normotensive anesthetized Wistar rat assessed as decrease in systolic blood pressure at 2 mg/kg, iv administered as single dose measured 60 mins post dose relative to control2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID229436Selectivity ratio against serotonin 5-HT1 receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID35309Binding affinity towards cloned human alpha-1D adrenergic receptor was determined using [125]-HEAT as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID37478Binding affinity was tested on human Alpha-1B adrenergic receptor1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID239202Binding constant measured against Alpha-1A adrenergic receptor in human prostate; +++:highly active2005Bioorganic & medicinal chemistry letters, Feb-01, Volume: 15, Issue:3
Pharmacophore identification of alpha(1A)-adrenoceptor antagonists.
AID36468In vitro antagonism against Alpha-1A adrenergic receptor using phenylephrine (PE) challenge in dog prostate1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID36389Compound at 1 uM was tested for the inhibition of radioligand [3H]MK-912 binding to recombinant human alpha-2C adrenergic receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID86591Compound at 1 uM was tested for the inhibition of radioligand [3H]pyrilamine binding to peripheral histamine H1 receptor in guinea pig brain2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID32968In vitro binding affinity using [3H]prazosin as radioligand against adrenoceptor alpha 1A2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID229438Selectivity ratio against serotonin 5-HT1A receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID231524Ratio of binding affinity towards Alpha1d to Alpha-1A2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1323691Selectivity ratio of EC50 for human alpha1B adrenergic receptor expressed in CHOK1 cells co-expressing aequorin assessed as inhibition of agonist induced calcium mobilization to EC50 for alpha1A adrenergic receptor (unknown origin) assessed as inhibition 2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID321750Displacement of [125I]HEAT from human recombinant adrenergic alpha1A receptor2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
(Phenylpiperazinyl)cyclohexylureas: discovery of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID296252Binding affinity to human cloned adrenergic Alpha-1D receptor2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
(Arylpiperazinyl)cyclohexylsufonamides: discovery of alpha(1a/1d)-selective adrenergic receptor antagonists for the treatment of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID545216Selectivity ratio of Ki for human alpha1A adrenoceptor to Ki for human Alpha-1D adrenoceptor2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID36915In vitro antagonism against Alpha-1A adrenergic receptor using phenylephrine (PE) challenge in rat vas deferens1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID35938Binding affinity towards recombinant human alpha-2A adrenergic receptor was determined using [3H]MK-912 as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID36249Compound at 1 uM was tested for the inhibition of radioligand [3H]yohimbine binding to rat alpha-2B adrenergic receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID157616Inhibition of [3H]nitrendipine binding to phenylalkylamine-sensitive [Ca2+] L-type channels in rat cerebral cortex at 1 uM2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID37033In vitro antagonistic activity towards alpha-1A adrenergic receptor in rat vas deferens2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID545228Selectivity ratio of EC50 for alpha1D adrenoceptor in Wistar rat thoracic aorta to Ki for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID59533Intraurethral pressure (IUP) in Beagle dogs values are expressed as pseudo pA2 values.2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID229437Selectivity ratio against serotonin 5-HT17 receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID545223Selectivity ratio of EC50 for alpha1A adrenoceptor in Wistar rat vas deferens to EC50 for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID64468Binding affinity towards recombinant human Dopamine receptor D2L was determined using [3H]spiperone as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID86747Binding affinity towards central histamine H1 receptor was determined in guinea pig brain using [3H]-pyrilamine as radioligand; Not determined2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1320810Toxicity in conscious rat assessed as reduction in mean blood pressure at 1 mg/kg, po measured after 60 mins
AID86590Compound at 1 uM was tested for the inhibition of radioligand [3H]pyrilamine binding to central histamine H1 receptor in guinea pig brain2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID29126Antagonist dissociation constant in rat spleen, number of determinations => 3.2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID197368Compound was tested for selectivity in a challenge spontaneously hypertensive rat (SHR) model using an ascending in vitro dose paradigm1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID64182Compound at 1 uM was tested for the inhibition of radioligand [3H]spiperone binding to recombinant human Dopamine receptor D4.72000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID64652Compound at 1 uM was tested for the inhibition of radioligand [3H]spiperone binding to recombinant human Dopamine receptor D2S2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID36371Binding affinity towards rat alpha-2B adrenergic receptor was determined using [3H]yohimbine as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID229175Selectivity ratio against central Histamine H1 receptor; Not determined2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID229428Selectivity ratio against alpha-1a (Adrenergic Receptor-1a) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID1320518Selectivity ratio of IC50 for human full-length N-terminal SNAP-tagged alpha1D adrenoceptor to IC50 for human full-length N-terminal SNAP-tagged alpha1A adrenoceptor2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID62842Compound was tested for efficacy in a challenge intraurethral pressure (IUP) model using aged anesthetized dogs1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID36753Binding affinity was tested on human Alpha-1A adrenergic receptor1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID1296472Displacement of [125I] HEAT from human alpha1D adrenergic receptor expressed in Chlorocebus aethiops COS1 cell membranes incubated for 60 mins by liquid scintillation counting analysis2016Journal of medicinal chemistry, Apr-14, Volume: 59, Issue:7
Discovery of 5-Chloro-1-(5-chloro-2-(methylsulfonyl)benzyl)-2-imino-1,2-dihydropyridine-3-carboxamide (TAK-259) as a Novel, Selective, and Orally Active α1D Adrenoceptor Antagonist with Antiurinary Frequency Effects: Reducing Human Ether-a-go-go-Related G
AID1470705Antagonist activity at recombinant human alpha1a adrenergic receptor expressed in human Chem1 cell membrane assessed as reduction in ephinephrine-induced calcium mobilization at 1 uM by fluoforte dye based fluorescence assay relative to ephinephrine2017European journal of medicinal chemistry, May-26, Volume: 132Novel aryl piperazines for alleviation of 'andropause' associated prostatic disorders and depression.
AID5936350% reduction in agonist induced pressor response in anesthetized dog1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID64664Binding affinity towards recombinant human Dopamine receptor D2S was determined using [3H]spiperone as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID6590Binding affinity towards recombinant human 5-hydroxytryptamine 7 receptor was determined using [3H]LSD as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID232246Selectivity ratio (antolog[pA2rat vas deferens/pA2 rat spleen]) of the compound2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID1320517Selectivity ratio of IC50 for human full-length N-terminal SNAP-tagged alpha1B adrenoceptor to IC50 for human full-length N-terminal SNAP-tagged alpha1A adrenoceptor2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID32975In vitro binding affinity using [3H]prazosin as radioligand against adrenoceptor alpha 1d expressed in LTK cell2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID1743294Antagonist activity at human alpha1A receptor transfected in HEK293 cells co-transfected with Galpha16 assessed as reduction in intracellular calcium release incubated for 40 mins by Fluo-4AM dye based fluorescence assay2020European journal of medicinal chemistry, Nov-01, Volume: 205The one-pot synthesis of butyl-1H-indol-3-alkylcarboxylic acid derivatives in ionic liquid as potent dual-acting agent for management of BPH.
AID625278FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of no concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID35154In vitro antagonism against Alpha-1B adrenergic receptor using phenylephrine (PE) challenge in rat spleen1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID545215Selectivity ratio of Ki for human Alpha-1D adrenoceptor to Ki for human alpha1B adrenoceptor2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID1320512Antagonist activity at human full-length N-terminal SNAP-tagged alpha1A adrenoceptor expressed in HEK293 cells assessed as inhibition of agonist-induced calcium mobilization preincubated for 10 mins followed by agonist addition by fluo-4 AM dye-based assa2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID32974In vitro binding affinity using [3H]prazosin as radioligand against adrenoceptor alpha 1b expressed in LTK cell2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID1743296Antagonist activity at human alpha1D receptor transfected in HEK293 cells co-transfected with Galpha16 assessed as reduction in intracellular calcium release incubated for 40 mins by Fluo-4AM dye based fluorescence assay2020European journal of medicinal chemistry, Nov-01, Volume: 205The one-pot synthesis of butyl-1H-indol-3-alkylcarboxylic acid derivatives in ionic liquid as potent dual-acting agent for management of BPH.
AID545226Selectivity ratio of EC50 for alpha1A adrenoceptor in Wistar rat vas deferens to Ki for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID36466In vitro for the displacement of [3H]prazosin binding to bovine Alpha-1A adrenergic receptor1997Journal of medicinal chemistry, Aug-15, Volume: 40, Issue:17
N-arylpiperazinyl-N'-propylamino derivatives of heteroaryl amides as functional uroselective alpha 1-adrenoceptor antagonists.
AID37205Binding affinity towards cloned human alpha-1B adrenergic receptor was determined using [125]-HEAT as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID545221Selectivity ratio of Ki for alpha1A adrenoceptor in Wistar rat vas deferens to Ki for Alpha-1D adrenoceptor in Wistar rat thoracic aorta2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID35613In vitro antagonism against Alpha-1D adrenergic receptor using phenylephrine (PE) challenge in rat aorta1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID36252Binding affinity against rat Alpha-2B adrenergic receptor using [3H]rauwolscine as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID36478Binding affinity against human adrenergic receptor subtype Alpha-1A adrenergic receptor using [3H]prazosin as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID3685Binding affinity towards 5-hydroxytryptamine 1 receptor was determined in rat cerebral cortex using [3H]5-HT as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID545225Selectivity ratio of EC50 for alpha1D adrenoceptor in Wistar rat thoracic aorta to EC50 for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1323687Intrinsic activity at alpha1A adrenergic receptor (unknown origin) assessed as inhibition of agonist induced effect preincubated for 30 mins followed by agonist addition measured after 5 hrs in presence of CCF4-AM by cell based beta lactamase reporter gen2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID290866Binding affinity to human cloned adrenergic alpha-1a receptor2007Bioorganic & medicinal chemistry letters, Jul-15, Volume: 17, Issue:14
(Phenylpiperidinyl)cyclohexylsulfonamides: development of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID545212Displacement of [3H]prazosin from human Alpha-1B adrenoceptor expressed in CHO cells2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID545227Selectivity ratio of Ki for alpha1A adrenoceptor in Wistar rat vas deferens to EC50 for Alpha-1D adrenoceptor in Wistar rat thoracic aorta2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID1323701Hypotensive activity in normotensive anesthetized Wistar rat assessed as decrease in systolic blood pressure at 1 mg/kg, iv administered as single dose measured 60 mins post dose relative to control2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID1636472Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 44.8 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of N2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID35303Binding affinity against human adrenergic receptor subtype Alpha-1D adrenergic receptor using [3H]prazosin as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID36469In vitro antagonistic activity against alpha-1A receptor in dog prostate.2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID224639Inhibition of A61603-induced contraction; n=4 and data for each concentration was averaged (SEM<10%) in rat.2000Journal of medicinal chemistry, Jul-13, Volume: 43, Issue:14
In vitro and in vivo evaluation of dihydropyrimidinone C-5 amides as potent and selective alpha(1A) receptor antagonists for the treatment of benign prostatic hyperplasia.
AID29124Antagonist dissociation constant in dog prostate, number of determinations => 3.2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID1320516Antagonist activity at human full-length N-terminal SNAP-tagged alpha1D adrenoceptor expressed in HEK293 cells assessed as inhibition of agonist-induced calcium mobilization preincubated for 10 mins followed by agonist addition by fluo-4 AM dye-based assa2016Journal of medicinal chemistry, Oct-27, Volume: 59, Issue:20
Design, Synthesis, and Biological Evaluation of Novel Tetrahydroprotoberberine Derivatives (THPBs) as Selective α
AID56037Inhibition of [3H]nitrendipine binding to Dihydropyridine-sensitive L-type [Ca2+] channel in rat cerebral cortex at 1 uM2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID545222Selectivity ratio of Ki for alpha1D adrenoceptor in Wistar rat thoracic aorta to Ki for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID91718Displacement of [3H]-idazoxan from imidazoline receptor I-2 of rat cerebral cortex2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID196110Antagonist dissociation equilibrium constant was tested against rat prosta contraction2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID296251Binding affinity to human cloned adrenergic alpha-1B receptor2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
(Arylpiperazinyl)cyclohexylsufonamides: discovery of alpha(1a/1d)-selective adrenergic receptor antagonists for the treatment of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS).
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID35926Compound at 1 uM was tested for the inhibition of radioligand [3H]MK-912 binding to recombinant human alpha-2A adrenergic receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID545220Selectivity ratio of Ki for alpha1A adrenoceptor in Wistar rat vas deferens to Ki for Alpha-1B adrenoceptor in Wistar rat spleen2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID1296473Selectivity ratio of Ki for human alpha1A adrenergic receptor to Ki for human alpha1D adrenergic receptor2016Journal of medicinal chemistry, Apr-14, Volume: 59, Issue:7
Discovery of 5-Chloro-1-(5-chloro-2-(methylsulfonyl)benzyl)-2-imino-1,2-dihydropyridine-3-carboxamide (TAK-259) as a Novel, Selective, and Orally Active α1D Adrenoceptor Antagonist with Antiurinary Frequency Effects: Reducing Human Ether-a-go-go-Related G
AID190260Pseudo ED50 in Spontaneously Hypertensive Rat (SHR) model. Number determinations => 3.2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID290868Binding affinity to human cloned adrenergic alpha-1d receptor2007Bioorganic & medicinal chemistry letters, Jul-15, Volume: 17, Issue:14
(Phenylpiperidinyl)cyclohexylsulfonamides: development of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID62832In vivo antagonist dissociation constant in intaraurethral pressure model in dogs.2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID5936450% reduction in intraurethral pressure (IUP) in response to hypogastric nerve stimulation or agonist (phenylephrine or norepinephrine) administration in anesthetized dog1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID64831Compound at 1 uM was tested for the inhibition of radioligand [3H]spiperone binding to recombinant human Dopamine receptor D32000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID195356Antagonist dissociation equilibrium constant was tested against rat aorta contraction2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID692048Selectivity ratio of Ki for rat liver adrenergic alpha1B receptor to Ki for rat salivary gland adrenergic alpha 1A2011European journal of medicinal chemistry, Jul, Volume: 46, Issue:7
Discovery of LASSBio-772, a 1,3-benzodioxole N-phenylpiperazine derivative with potent alpha 1A/D-adrenergic receptor blocking properties.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID65117Binding affinity towards recombinant human Dopamine receptor D3 was determined using [3H]spiperone as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID36483Binding affinity towards cloned human alpha-1A adrenergic receptor was determined using [125]-HEAT as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID1323695Hypotensive activity in normotensive anesthetized Wistar rat assessed as decrease in diastolic blood pressure at 1 mg/kg, iv administered as single dose measured 60 mins post dose relative to control2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID24855Antagonist dissociation constant in rat vas deferens, number of determinations => 3.2000Journal of medicinal chemistry, Apr-20, Volume: 43, Issue:8
Structure-activity studies for a novel series of tricyclic substituted hexahydrobenz[e]isoindole alpha(1A) adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia (BPH).
AID545213Displacement of [3H]prazosin from human Alpha-1D adrenoceptor expressed in CHO cells2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID3814Binding affinity towards recombinant human Compound at 1 uM was tested for the inhibition of radioligand [3H]8-OH-DPAT binding to recombinant human 5-hydroxytryptamine 1A receptor was determined using [3H]8-OH-DPAT as radioligand2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID545219Antagonist activity at Alpha-1D adrenoceptor in Wistar rat thoracic aorta assessed as noradrenaline induced contractions after 30 mins2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID229372Ratio of intraurethral pressure to that of pressor response in dog.1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID197367Antagonistic activity in spontaneously hypertensive rat model.2001Journal of medicinal chemistry, Jun-07, Volume: 44, Issue:12
Structure-activity studies for a novel series of bicyclic substituted hexahydrobenz[e]isoindole alpha1A adrenoceptor antagonists as potential agents for the symptomatic treatment of benign prostatic hyperplasia.
AID321752Displacement of [125I]HEAT from human recombinant adrenergic alpha1C receptor2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
(Phenylpiperazinyl)cyclohexylureas: discovery of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID37200Binding affinity against human adrenergic receptor subtype Alpha-1B adrenergic receptor using [3H]prazosin as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID1296474Selectivity ratio of Ki for human alpha1B adrenergic receptor to Ki for human alpha1D adrenergic receptor2016Journal of medicinal chemistry, Apr-14, Volume: 59, Issue:7
Discovery of 5-Chloro-1-(5-chloro-2-(methylsulfonyl)benzyl)-2-imino-1,2-dihydropyridine-3-carboxamide (TAK-259) as a Novel, Selective, and Orally Active α1D Adrenoceptor Antagonist with Antiurinary Frequency Effects: Reducing Human Ether-a-go-go-Related G
AID296250Binding affinity to human cloned adrenergic alpha-1A receptor2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
(Arylpiperazinyl)cyclohexylsufonamides: discovery of alpha(1a/1d)-selective adrenergic receptor antagonists for the treatment of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS).
AID231523Ratio of binding affinity towards Alpha1b to Alpha-1A2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID37056Antagonistic activity against alpha 1A/1L receptor was assessed in a rabbit bladder neck functional assay1997Journal of medicinal chemistry, Aug-15, Volume: 40, Issue:17
N-arylpiperazinyl-N'-propylamino derivatives of heteroaryl amides as functional uroselective alpha 1-adrenoceptor antagonists.
AID224975Duration of action with repeated challenges of A61603 agonist, n=4, data from each time point was averaged (SEM<10%) in rat.2000Journal of medicinal chemistry, Jul-13, Volume: 43, Issue:14
In vitro and in vivo evaluation of dihydropyrimidinone C-5 amides as potent and selective alpha(1A) receptor antagonists for the treatment of benign prostatic hyperplasia.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1320809Reduction in intraurethral pressure in conscious rat at 1 mg/kg, po measured after 60 mins
AID6581Compound at 1 uM was tested for the inhibition of radioligand [3H]LSD binding to recombinant human 5-hydroxytryptamine 7 receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID36124pA2 for Alpha-1 adrenergic receptor from human prostate.1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Pharmacological options in the treatment of benign prostatic hyperplasia.
AID157617Inhibition of [3H]nitrendipine binding to phenylalkylamine-sensitive [Ca2+] L-type channels in rat cerebral cortex2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID64322Compound at 1 uM was tested for the inhibition of radioligand [3H]spiperone binding to recombinant human Dopamine receptor D2L2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID229430Selectivity ratio against alpha-2a (Adrenergic Receptor-2a) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1323699Hypotensive activity in normotensive anesthetized Wistar rat assessed as decrease in diastolic blood pressure at 2 mg/kg, iv administered as single dose measured 60 mins post dose relative to control2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Arylsulfonamide derivatives of (aryloxy)ethyl pyrrolidines and piperidines as α
AID229426Selectivity ratio against D2S( dopaminergic) receptor2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
Design, synthesis, and structure-activity relationships of phthalimide-phenylpiperazines: a novel series of potent and selective alpha(1)(a)-adrenergic receptor antagonists.
AID36397Binding affinity against human Alpha-2C adrenergic receptor using [3H]rauwolscine as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID545211Displacement of [3H]prazosin from human alpha1A adrenoceptor expressed in CHO cells2010European journal of medicinal chemistry, Dec, Volume: 45, Issue:12
Synthesis and α1-adrenoceptor antagonist activity of tamsulosin analogues.
AID290867Binding affinity to human cloned adrenergic alpha-1b receptor2007Bioorganic & medicinal chemistry letters, Jul-15, Volume: 17, Issue:14
(Phenylpiperidinyl)cyclohexylsulfonamides: development of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID321751Displacement of [125I]HEAT from human recombinant adrenergic Alpha-1B receptor2008Bioorganic & medicinal chemistry letters, Jan-15, Volume: 18, Issue:2
(Phenylpiperazinyl)cyclohexylureas: discovery of alpha1a/1d-selective adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
AID35936Binding affinity against human adrenergic receptor subtype Alpha-2A adrenergic receptor using [3H]rauwolscine as radioligand1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Synthesis and pharmacological characterization of 3-[2-((3aR,9bR)-cis-6-methoxy-2,3,3a,4,5,9b-hexahydro-1H-benz[e] isoindol-2-yl)ethyl]pyrido-[3',4':4,5]thieno[3,2-d]pyrimidine-2,4 (1H,3H)-dione (A-131701): a uroselective alpha 1A adrenoceptor antagonist
AID1345971Human alpha1D-adrenoceptor (Adrenoceptors)1997British journal of pharmacology, Jul, Volume: 121, Issue:6
Pharmacological pleiotropism of the human recombinant alpha1A-adrenoceptor: implications for alpha1-adrenoceptor classification.
AID1345908Human alpha1A-adrenoceptor (Adrenoceptors)1999British journal of pharmacology, May, Volume: 127, Issue:1
In vitro alpha1-adrenoceptor pharmacology of Ro 70-0004 and RS-100329, novel alpha1A-adrenoceptor selective antagonists.
AID1345971Human alpha1D-adrenoceptor (Adrenoceptors)1999British journal of pharmacology, May, Volume: 127, Issue:1
In vitro alpha1-adrenoceptor pharmacology of Ro 70-0004 and RS-100329, novel alpha1A-adrenoceptor selective antagonists.
AID1346000Human alpha1B-adrenoceptor (Adrenoceptors)1995Molecular pharmacology, Aug, Volume: 48, Issue:2
KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues.
AID1345908Human alpha1A-adrenoceptor (Adrenoceptors)1998FEBS letters, Jan-30, Volume: 422, Issue:2
Molecular cloning, genomic characterization and expression of novel human alpha1A-adrenoceptor isoforms.
AID1346000Human alpha1B-adrenoceptor (Adrenoceptors)1997British journal of pharmacology, Jul, Volume: 121, Issue:6
Pharmacological pleiotropism of the human recombinant alpha1A-adrenoceptor: implications for alpha1-adrenoceptor classification.
AID1345908Human alpha1A-adrenoceptor (Adrenoceptors)1997British journal of pharmacology, Jul, Volume: 121, Issue:6
Pharmacological pleiotropism of the human recombinant alpha1A-adrenoceptor: implications for alpha1-adrenoceptor classification.
AID1345971Human alpha1D-adrenoceptor (Adrenoceptors)1995Molecular pharmacology, Aug, Volume: 48, Issue:2
KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues.
AID1346000Human alpha1B-adrenoceptor (Adrenoceptors)1999British journal of pharmacology, May, Volume: 127, Issue:1
In vitro alpha1-adrenoceptor pharmacology of Ro 70-0004 and RS-100329, novel alpha1A-adrenoceptor selective antagonists.
AID1345908Human alpha1A-adrenoceptor (Adrenoceptors)1999European journal of pharmacology, Apr-16, Volume: 370, Issue:3
Human cloned alpha1A-adrenoceptor isoforms display alpha1L-adrenoceptor pharmacology in functional studies.
AID1345908Human alpha1A-adrenoceptor (Adrenoceptors)1995Molecular pharmacology, Aug, Volume: 48, Issue:2
KMD-3213, a novel, potent, alpha 1a-adrenoceptor-selective antagonist: characterization using recombinant human alpha 1-adrenoceptors and native tissues.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,342)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (0.07)18.7374
1990's124 (9.24)18.2507
2000's451 (33.61)29.6817
2010's599 (44.63)24.3611
2020's167 (12.44)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 132.78

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index132.78 (24.57)
Research Supply Index7.56 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index247.04 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (132.78)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials468 (32.05%)5.53%
Reviews198 (13.56%)6.00%
Case Studies59 (4.04%)4.05%
Observational28 (1.92%)0.25%
Other707 (48.42%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (195)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia [NCT05834270]60 participants (Actual)Interventional2022-05-01Completed
Pharmacokinetics, Safety and Tolerability of Single Oral Doses (0.1, 0.2, 0.4 and 0.8 mg) of Tamsulosin Hydrochloride in Children With Voiding Disorders [NCT02266524]Phase 148 participants (Actual)Interventional2005-01-31Completed
PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia [NCT02121613]Phase 4833 participants (Actual)Interventional2014-04-30Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions [NCT01149746]Phase 132 participants (Actual)Interventional2004-12-31Completed
"An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tamsulosin HCl Tablet and Astellas Phama Korea Inc. Harnal-D in Healthy Volunteers" [NCT03887858]Phase 130 participants (Actual)Interventional2019-03-11Completed
Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride [NCT03879746]Phase 3160 participants (Anticipated)Interventional2019-04-30Not yet recruiting
Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study [NCT01167062]Phase 4120 participants (Anticipated)Interventional2010-06-30Recruiting
The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study [NCT04597372]Phase 2154 participants (Anticipated)Interventional2021-11-03Recruiting
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation [NCT03750656]Phase 46 participants (Actual)Interventional2018-11-12Terminated(stopped due to Not accruing patients quickly enough)
Effect of Tamsulosin and Nifedipine on the Elimination of Fragments After Extracorporeal Shock Waves Lithotripsy in Patients With Kidney Stones - a Prospective, Double-blind and Randomized Study [NCT01215708]Phase 3136 participants (Actual)Interventional2006-08-31Active, not recruiting
PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms [NCT05415748]Phase 431 participants (Actual)Interventional2021-09-18Active, not recruiting
TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients With BPH. [NCT05401032]Phase 270 participants (Anticipated)Interventional2022-06-30Not yet recruiting
Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection: a Double-blind Placebo-controlled Clinical Trial [NCT05941806]Phase 3220 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center [NCT02827578]Phase 3588 participants (Anticipated)Interventional2016-01-31Recruiting
Benign Prostatic Hyperplasia and Ischemic Heart DIsease [NCT03856242]Phase 483 participants (Actual)Interventional2015-09-01Completed
Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair [NCT04491526]Phase 4634 participants (Anticipated)Interventional2020-11-01Recruiting
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin [NCT05197088]Phase 3110 participants (Anticipated)Interventional2022-01-09Not yet recruiting
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery [NCT02919436]Phase 4610 participants (Actual)Interventional2016-03-31Completed
[NCT02034604]Phase 4194 participants (Actual)Interventional2013-12-31Completed
"An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tamsulosin HCl Tablet and Astellas Phama Korea Inc. Harnal-D in Healthy Volunteers" [NCT03887871]Phase 130 participants (Actual)Interventional2019-03-11Completed
[NCT03246880]Phase 3455 participants (Actual)Interventional2015-09-30Completed
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention [NCT02684344]5 participants (Actual)Interventional2016-02-29Terminated(stopped due to Lack of enrollment)
Comparative Efficacy of DuodartTM Versus Watchful Waiting With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Symptomatic BPH [NCT01294592]Phase 4742 participants (Actual)Interventional2010-12-22Completed
Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure [NCT02033798]34 participants (Anticipated)Interventional2014-02-28Not yet recruiting
An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers [NCT02239484]Phase 130 participants (Actual)Interventional2014-03-31Completed
Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica [NCT03614052]Phase 414 participants (Actual)Interventional2018-06-01Terminated(stopped due to Problems with the number of participants)
Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty [NCT03808155]Phase 4170 participants (Anticipated)Interventional2019-08-01Recruiting
The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis [NCT03799120]Phase 480 participants (Anticipated)Interventional2019-02-18Enrolling by invitation
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers [NCT02180997]Phase 136 participants (Actual)Interventional2014-07-31Completed
[NCT02443844]Phase 440 participants (Anticipated)Interventional2015-02-28Recruiting
A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS [NCT02303769]Phase 3309 participants (Actual)Interventional2014-03-31Completed
A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia [NCT02390882]Phase 3494 participants (Actual)Interventional2014-10-31Completed
Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia [NCT02038868]Phase 2320 participants (Actual)Interventional2013-07-22Completed
The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia [NCT03144596]Phase 463 participants (Actual)Interventional2015-10-29Completed
A Single-Dose, Randomised, Open-Label, Two-Period Crossover Study to Determine the Bioequivalence of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in the Fed State in Healthy Adult Male Subjects [NCT02058576]Phase 177 participants (Actual)Interventional2014-02-11Completed
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis [NCT05759767]120 participants (Anticipated)Interventional2021-02-01Active, not recruiting
Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome:A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study [NCT05890235]Phase 4323 participants (Actual)Interventional2018-11-16Completed
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Ur [NCT02757768]Phase 4715 participants (Actual)Interventional2016-06-13Completed
An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers) [NCT02264184]Phase 124 participants (Actual)Interventional2008-09-30Completed
Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones [NCT04819828]Phase 460 participants (Actual)Interventional2010-01-01Completed
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial [NCT02095665]Phase 422 participants (Actual)Interventional2014-01-01Completed
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy [NCT05725122]82 participants (Actual)Interventional2018-02-01Completed
A Study Evaluating the Therapeutic Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy [NCT05537272]Phase 4120 participants (Anticipated)Interventional2022-09-01Enrolling by invitation
A Phase I/II Evaluation of Bromocriptine, Metoprolol and Tamsulosin Combination Therapy in Eyes With Non-Central Diabetic Macular Edema [NCT03384524]Phase 1/Phase 20 participants (Actual)Interventional2018-03-31Withdrawn(stopped due to withdrawn during planning stages)
Clinical Study of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Device Used in Patients With Benign Prostatic Hyperplasia [NCT05531344]Phase 2/Phase 3160 participants (Actual)Interventional2020-08-20Completed
A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy [NCT01209988]220 participants (Anticipated)Interventional2010-04-30Recruiting
A Phase 1, Single-centre, Double-blind, Randomized, Placebo-controlled, Two-cohort, Two-period Crossover Study of the Hemodynamic Interactions Between Avanafil and Two α-Adrenergic Blockers, Doxazosin and Tamsulosin, in Middle-aged Healthy Male Subjects [NCT01100021]Phase 148 participants (Actual)Interventional2010-02-28Completed
A Multicenter, Prospective, Randomized, Controlled Clinical Study of Ningmitai Capsule to Promote the Passage of Residual Fragments After Ureteroscopic Lithotripsy [NCT06105827]Phase 4251 participants (Actual)Interventional2016-10-02Completed
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL [NCT01560091]Phase 30 participants (Actual)Interventional2012-03-31Withdrawn(stopped due to accrual of subjects did not occur as anticipated)
An Open-label, Randomized, Single Dose, Two-Period Crossover Study to Determine the Bioavailability of a Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.2mg) Relative to Co-administration of Dutasteride 0.5m [NCT01254071]Phase 186 participants (Actual)Interventional2010-09-10Completed
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters [NCT01028014]56 participants (Actual)Interventional2010-04-30Completed
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male [NCT01018511]Phase 31,334 participants (Actual)Interventional2010-01-31Completed
An Open-label, Parallel Group, Randomized, Two-way Crossover, Multiple Dose Study to Compare the Pharmacokinetic Profiles of Solifenacin Succinate and Tamsulosin HCl Following Co-administration of Single Entity Tablets and Administration of Three Differen [NCT02634489]Phase 146 participants (Actual)Interventional2009-03-31Completed
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy [NCT00510406]Phase 2919 participants (Actual)Interventional2007-01-31Completed
A Parallel Group Study With Three Different α-antagonists and Placebo Once Daily Over Three Weeks to Assess Their Influence on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Voluntee [NCT02266537]Phase 197 participants (Actual)Interventional2005-11-30Completed
A Phase 1 Study to Evaluate the Effect of Steady State Solifenacin and Mirabegron on the Steady State Pharmacokinetics of Tamsulosin HCl in Healthy Male Subjects [NCT02169713]Phase 120 participants (Actual)Interventional2014-05-31Completed
An Open-label, Prospective Interventional Study of the Tolerability and Efficacy of Oral Harnalidge® OCAS® (Tamsulosin) 0.4 mg in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2 mg [NCT02180789]Phase 4100 participants (Actual)Interventional2013-03-31Completed
Randomized Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Discomfort in the Pediatric Population [NCT02483793]60 participants (Anticipated)Interventional2015-07-31Not yet recruiting
Prophylactic Alpha-blockers in the Prevention of Post-operative Urinary Retention After Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Trial [NCT03314259]Early Phase 1300 participants (Anticipated)Interventional2017-12-01Not yet recruiting
Prophylactic Administration of Alpha Blockers for Prevention of Post Operative Urinary Retention in Males Undergoing Open Inguinal Hernia Repair Under Spinal Anaesthesia. [NCT03976934]Phase 1/Phase 2100 participants (Actual)Interventional2020-02-01Completed
Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT03314025]Phase 2158 participants (Anticipated)Interventional2017-10-06Recruiting
THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS [NCT06124066]Phase 442 participants (Actual)Interventional2022-07-01Completed
A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule (Tamsulosin Pellet From Meppel Plant and Nishine Plant) Under Fed and Fasted Conditions in Chinese Healthy [NCT02138773]Phase 180 participants (Actual)Interventional2014-04-30Completed
A Single-Dose, Randomised, Open-Label, Two-Period Crossover Study to Determine the Bioequivalence of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in the Fasted State in Healthy Adult Male Subjects [NCT02052713]Phase 178 participants (Actual)Interventional2014-02-19Completed
A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers [NCT02072213]Phase 136 participants (Actual)Interventional2013-08-31Completed
An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers. [NCT04485585]Phase 136 participants (Actual)Interventional2020-07-20Completed
Comparison of Silodosin Versus Tamsulosin on Passage of Acutely Obstructing Ureteral Calculi (History of Last 4 Weeks) in Medical Expulsive Therapy [NCT05977647]Phase 4240 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Post-operative Urinary Retention (POUR) Following Thoracic Surgery [NCT03609580]Phase 1/Phase 2127 participants (Anticipated)Interventional2018-05-07Recruiting
A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical O [NCT00090103]Phase 34,844 participants (Actual)Interventional2003-11-30Completed
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI [NCT05790902]Phase 1142 participants (Actual)Interventional2022-09-01Completed
Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin [NCT00606983]Phase 3100 participants (Anticipated)Interventional2007-05-31Completed
An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms [NCT02715024]Phase 452 participants (Actual)Interventional2007-09-30Completed
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg [NCT00954889]220 participants (Actual)Interventional2009-08-31Active, not recruiting
Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial [NCT04159077]Phase 3350 participants (Anticipated)Interventional2021-07-30Not yet recruiting
Effect of Preoperative Single-dose Tamsulosin on Postoperative Urinary Retention After Mid-urethral Sling Placement: a Randomized, Double-blinded, Placebo-controlled Trial [NCT05753670]Phase 3160 participants (Anticipated)Interventional2023-07-01Recruiting
Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women [NCT05439902]60 participants (Anticipated)Interventional2022-10-05Recruiting
The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study [NCT04434378]Phase 4170 participants (Actual)Interventional2017-11-16Terminated(stopped due to Significant difference not reached on interim analysis)
the Therapeutic Effect Treated With Tamsulosin After ESWL in Urinary Calculus [NCT01010048]Phase 4120 participants (Anticipated)Interventional2009-10-31Recruiting
A Two Phase, Double-blinded, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia [NCT02244294]Phase 2176 participants (Actual)Interventional2001-03-31Completed
Behavior and Exercise Versus Drug Treatment in Men With Nocturia [NCT00824200]Phase 472 participants (Actual)Interventional2008-07-31Completed
Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study [NCT00831701]100 participants (Actual)Interventional2006-09-30Completed
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH) [NCT04107896]Phase 4141 participants (Actual)Interventional2017-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride [NCT00771394]Phase 4638 participants (Actual)Interventional2008-10-31Completed
A Phase IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months [NCT00796614]Phase 2/Phase 3231 participants (Actual)Interventional2008-01-31Completed
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients [NCT00448123]127 participants (Actual)Interventional2007-02-28Completed
[NCT02862483]Phase 3330 participants (Anticipated)Interventional2016-03-31Recruiting
A Phase 3, Randomized, Double Blind, Placebo and Tamsulosin Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil Once a Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplas [NCT00861757]Phase 3612 participants (Actual)Interventional2009-03-31Completed
Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms [NCT00913315]30 participants (Anticipated)Interventional2009-08-31Not yet recruiting
The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH [NCT01404637]150 participants (Anticipated)Interventional2011-07-31Not yet recruiting
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia: A Prospective Randomized Multicenter Trial [NCT00687388]Phase 40 participants (Actual)Interventional2008-05-31Withdrawn(stopped due to in order to prepare a new clinical trial to evaluate with pathological change)
Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese [NCT05570084]Phase 380 participants (Anticipated)Interventional2022-05-31Recruiting
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 After a Single Oral Dose in Healthy Male Subjects [NCT02615782]Phase 116 participants (Actual)Interventional2015-12-31Completed
A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms [NCT01880619]Phase 4131 participants (Actual)Interventional2013-01-31Completed
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy [NCT00209131]24 participants (Actual)Interventional2005-04-30Terminated(stopped due to Due to frequent turnover of research coordinators and thus poor study accrual.)
Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia) [NCT02245503]7,391 participants (Actual)Observational2003-05-31Completed
An Uncontrolled, Open-label, Titration, Long-term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-study Investigating Low, Medium and High Dose Ranges. [NCT00340704]Phase 2143 participants (Actual)Interventional2006-04-30Completed
A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With [NCT00507455]Phase 2222 participants (Actual)Interventional2007-06-30Completed
A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects. [NCT01943487]Phase 136 participants (Actual)Interventional2009-08-31Completed
Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin [NCT04994431]Phase 460 participants (Anticipated)Interventional2021-08-01Recruiting
An Open-label, Randomized, Two-way Crossover, Multiple Dose Study to Evaluate the Steady State Pharmacokinetics of the Two Final Combination Tablet Formulations (EC905; Tamsulosin HCl/ Solifenacin Succinate; 0.4 mg/6 mg and 0.4 mg/9 mg) in Healthy Male Vo [NCT01953848]Phase 127 participants (Actual)Interventional2010-04-30Completed
An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®) [NCT01953887]Phase 130 participants (Actual)Interventional2010-03-31Completed
An Open Label, Single Sequence, Three Period, Drug-Drug Interaction Study To Examine The Pharmacokinetics Of Dutasteride And Tamsulosin And Their Interactions In Chinese Male Healthy Volunteers [NCT01957189]Phase 124 participants (Actual)Interventional2013-10-25Completed
Ciprofloxacin or Tamsulosin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Randomized, Double-blind Trial [NCT04552431]Phase 2196 participants (Actual)Interventional1997-09-30Completed
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial [NCT03709992]200 participants (Anticipated)Interventional2020-12-18Suspended(stopped due to Because of COVID-19 Crisis)
Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospecti [NCT01604811]Phase 4206 participants (Actual)Interventional2012-06-30Completed
EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA. [NCT02279615]Phase 4200 participants (Anticipated)Interventional2021-12-31Not yet recruiting
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients [NCT00600405]81 participants (Actual)Interventional2006-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia [NCT00540124]Phase 2151 participants (Actual)Interventional2007-10-31Completed
Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease. [NCT04359979]50 participants (Anticipated)Interventional2020-05-01Recruiting
Combined Behavioral and Drug Treatment of Overactive Bladder in Men [NCT01175382]Phase 2/Phase 3204 participants (Actual)Interventional2010-07-31Completed
An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associa [NCT01021332]Phase 31,067 participants (Actual)Interventional2010-04-26Completed
Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) [NCT02244320]4,150 participants (Actual)Observational2002-09-30Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia [NCT00970632]Phase 3511 participants (Actual)Interventional2009-10-31Completed
[NCT00451061]Phase 4120 participants (Anticipated)Interventional2007-04-30Not yet recruiting
An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia [NCT02244255]Phase 41,993 participants (Actual)Interventional1998-08-31Completed
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin [NCT01489696]Phase 148 participants (Actual)Interventional2010-08-31Completed
An Open-label, Randomized, Single Dose, Multi-stage, Cross-over Study to Determine the Relative Bioavailability of Fixed Dose Combination Products Containing a 3-oblong Dutasteride Soft Gel Capsule and Tamsulosin (0.5 mg Dutasteride /0.2 mg Tamsulosin HCl [NCT01495026]Phase 163 participants (Actual)Interventional2011-11-06Completed
Phase II Study Comparing Two Groups of Patients Undergoing ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin [NCT00478998]Phase 20 participants InterventionalNot yet recruiting
The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms: A Prospective Randomized Study [NCT03274700]Early Phase 180 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency: A Pilot Study. [NCT06020963]100 participants (Anticipated)Interventional2023-08-11Recruiting
Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial [NCT04325880]Phase 3240 participants (Anticipated)Interventional2021-12-01Recruiting
Prospective Observational Trial of Combination Therapy of Tadalafil 5mg Plus Tamsulosinmg for Men With Lower Urinary Tract Symptoms and Erectile Dysfunction [NCT04383093]75 participants (Actual)Observational2017-01-01Completed
A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia [NCT01673490]Phase 459 participants (Actual)Interventional2012-06-29Terminated(stopped due to The sole investigative site refused to accept the amended protocol and declined to continue the study. There was no safety signal nor any other reason.)
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery [NCT05657990]Early Phase 146 participants (Anticipated)Interventional2023-04-03Recruiting
A Randomized Trial of Tamsulosin and/or Dutasteride Versus Placebo to Relieve Urinary Symptoms After Brachytherapy for the Treatment of Localized Prostate Cancer [NCT00244309]Phase 3348 participants (Anticipated)Interventional2005-11-30Completed
Prostate Medication, Metabolism and Gut Microbiota [NCT06001619]Phase 4100 participants (Anticipated)Interventional2022-12-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Fre [NCT00333112]Phase 4398 participants (Actual)Interventional2006-05-31Completed
A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Wit [NCT00147654]Phase 4830 participants Interventional2004-11-30Completed
Valutazione Dell'Efficacia Del Trattamento Dell'Ipertrofia Prostatica Benigna Con Serenoa Repens Estratta Con CO2 + PEA (Palmitoilethanolamide) in Monoterapia o in Combinazione Alla Tamsulosina: ProSeRePEA Trial [NCT06181175]250 participants (Anticipated)Interventional2021-10-01Recruiting
Comparison of Silodosin vs. Tamsulosin on Spontaneous Passage of Acutely Obstructing Ureteral Calculi in Medical Expulsive Therapy [NCT02369744]Phase 41 participants (Actual)Interventional2013-03-31Terminated(stopped due to due to lack of suitable patient population)
Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial [NCT04682366]Phase 44 participants (Actual)Interventional2021-10-19Terminated(stopped due to Challenges in enrollment led to decission for termination)
Study of Tamsulosin for Urolithiasis in the Emergency Department [NCT00382265]Phase 4512 participants (Actual)Interventional2008-01-31Completed
[NCT00489723]0 participants Observational2007-05-31Recruiting
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia [NCT02972268]Phase 3780 participants (Actual)Interventional2016-02-01Completed
Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones [NCT00151567]Phase 3129 participants (Actual)Interventional2002-02-28Completed
The Pathophysiology and Treatment of Supine Hypertension in Patients With Autonomic Failure [NCT00223717]Phase 1152 participants (Actual)Interventional2001-01-31Completed
A Multi-center Randomized Placebo Controlled Trial Evaluating the Efficacy of JALYN in Improving Symptoms in Men Diagnosed With Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) [NCT01830829]Phase 31 participants (Actual)Interventional2013-04-30Terminated(stopped due to Difficulty in enrolling particpants)
Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions [NCT02417844]Phase 134 participants (Actual)Interventional2015-04-30Completed
Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones [NCT04557202]Phase 3120 participants (Actual)Interventional2017-09-01Completed
An Open-label, Randomized, Single Dose, Four-Period Crossover Study to Compare the Bioavailability of Fixed Dose Combination Capsule Formulations of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) With 10% and 15% of Enteric Coated Pellets With H [NCT01471678]Phase 127 participants (Actual)Interventional2011-06-30Completed
An Open-Label, Randomized, Single Dose Crossover Study to Determine the Bioequivalence of Duodart® 0.5mg/0.4mg (Capsule Formulation of Dutasteride 0.5mg and Tamsulosin Hydrochloride 0.4mg) Compared to Concomitant Dosing of Avodart® 0.5mg and Omnic® 0.4mg [NCT01657851]Phase 135 participants (Actual)Interventional2012-08-23Completed
A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH [NCT01736033]Phase 4545 participants (Actual)Interventional2012-02-29Active, not recruiting
Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition [NCT01747993]Phase 334 participants (Actual)Interventional2013-01-31Terminated(stopped due to low inclusion)
A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH [NCT01777269]Phase 4489 participants (Actual)Interventional2013-02-18Completed
Comparative Study Between Use of Alpha Blocker Versus Alpha Blocker and Antihistaminic in Management of Acute Renal Colic Prevent Pain Recurrence and Increase Expulsion Rate of Ureteric Stone ≤ 1cm [NCT05150899]100 participants (Anticipated)Observational [Patient Registry]2021-11-30Not yet recruiting
Open Label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics Between Coadministered Finasteride Tablet and Tamsulosin HCl Tablet and GL2701 Capsule, in Healthy Subjects [NCT01829893]Phase 126 participants (Actual)Interventional2012-01-31Completed
Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome [NCT02244268]3,629 participants (Actual)Observational2000-10-31Completed
A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tamsulosin on Tadalafil in Healthy Male Volunteers [NCT02247518]Phase 116 participants (Actual)Interventional2014-09-30Completed
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms [NCT01741454]Phase 4181 participants (Actual)Interventional2012-11-30Completed
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA [NCT01203371]Phase 30 participants (Actual)Interventional2011-01-01Withdrawn
Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy [NCT01435954]13,551 participants (Actual)Observational2010-08-31Completed
An Eight-week, Double-blind, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Daily Versus Placebo, in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms [NCT02244281]Phase 274 participants (Actual)Interventional2001-05-31Completed
Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH) [NCT02245529]982 participants (Actual)Observational2005-03-31Completed
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions [NCT01149733]Phase 132 participants (Actual)Interventional2004-11-30Completed
Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers. [NCT02494349]Phase 154 participants (Actual)Interventional2015-08-31Completed
Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study [NCT01533597]Phase 470 participants (Actual)Interventional2010-12-31Completed
"A Prospective Randomized Trial The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms" [NCT04807569]68 participants (Anticipated)Interventional2021-04-01Not yet recruiting
A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men [NCT02573311]Phase 31,117 participants (Actual)Interventional2015-09-23Completed
MICTUS (Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms): A Multicentre, Double-blind, Randomised, Parallel Group Study, Aimed at Characterising the Effect of Tamsulosin, an Uroselective α1- Receptor Blocking Agent, [NCT02244229]Phase 4403 participants (Actual)Interventional1998-04-30Completed
Observational Study About the Use of Tamsulosin in Patients With Benign Prostatic Hyperplasia [NCT02245555]1,060 participants (Actual)Observational2006-04-30Completed
Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders [NCT04232683]Early Phase 1100 participants (Actual)Interventional2019-12-18Active, not recruiting
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial [NCT04859660]Phase 2161 participants (Actual)Interventional2021-04-16Completed
Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial [NCT02486653]Phase 3158 participants (Actual)Interventional2015-08-31Completed
The Use of an Uroselective Alpha-1-antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery [NCT01568918]Phase 3350 participants (Anticipated)Interventional2012-05-31Recruiting
A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment [NCT01726270]Phase 2689 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia [NCT00379067]Phase 4882 participants (Actual)Interventional2005-10-31Completed
Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fasted Conditions [NCT02417831]Phase 134 participants (Actual)Interventional2015-04-30Completed
Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery [NCT03524339]Phase 2/Phase 3132 participants (Actual)Interventional2018-08-01Completed
Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair [NCT02958878]Phase 4210 participants (Actual)Interventional2017-01-03Completed
Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase. [NCT00359905]Phase 31,228 participants (Actual)Interventional2006-05-31Completed
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia [NCT04987892]Phase 4250 participants (Anticipated)Interventional2021-12-06Recruiting
A Phase III, Randomized Clinical Trial to Study the Safety and Efficacy of MK-906 (Finasteride) and Tamsulosin Administered Either Alone or Concomitantly in Patients With Benign Prostatic Hyperplasia (BPH) [NCT01534351]Phase 31 participants (Actual)Interventional2013-08-01Terminated(stopped due to Business Reasons)
Comparative Study Between Tadalafil Versus Tamsulosin as a Medical Expulsive Therapy for Lower Ureteric Stones [NCT04641507]Phase 4166 participants (Actual)Interventional2020-01-01Active, not recruiting
Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment [NCT03027115]Phase 4140 participants (Anticipated)Interventional2017-01-13Recruiting
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy and Endoscopic-Guided Percutaneous Nephrolithotomy: A Randomized Double-Blind Placebo Controlled Trial of Tadalafil, Tamsulosin and Combination [NCT03229889]Phase 4220 participants (Anticipated)Interventional2017-06-07Enrolling by invitation
Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial [NCT05494567]Phase 460 participants (Anticipated)Interventional2021-11-08Active, not recruiting
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Con [NCT05551221]Phase 4312 participants (Anticipated)Interventional2022-07-18Recruiting
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer [NCT04147806]Phase 230 participants (Anticipated)Interventional2016-08-01Active, not recruiting
Efficacy and Safety of a Single Transrectal Ultrasound(TRUS)-Guided Intraprostatic Injection of NX-1207 in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Phase III European Study [NCT02003742]Phase 3104 participants (Actual)Interventional2013-09-30Terminated(stopped due to The study was stopped because in two other clinical studies the drug was not superior in comparison with placebo)
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial [NCT01457573]Phase 410 participants (Actual)Interventional2011-10-31Completed
A Forty-Five Day, Open-label Study of the Symptomatic Relief Effects of FLOMAX® Capsules 0.4 mg Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia [NCT02244242]Phase 4493 participants (Actual)Interventional1998-07-31Completed
BLADDER (BPH, LUTS And Detrusor: Dual Effect Research) Study: A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study, Aimed at Characterising the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Act [NCT02245490]Phase 4153 participants (Actual)Interventional2003-01-31Completed
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial [NCT05818670]Phase 4160 participants (Actual)Interventional2020-11-11Completed
A Randomized, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride (0.5mg) and Tamsulosin (0.2mg) With Tamsulosin (0.2mg) Monotherapy, Administered Once Daily for 2 Years, on the Improvement of Sy [NCT02058368]Phase 3607 participants (Actual)Interventional2014-02-10Completed
An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride [NCT02509104]Phase 156 participants (Actual)Interventional2015-07-30Completed
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients [NCT02518971]Phase 3176 participants (Actual)Interventional2015-08-31Terminated(stopped due to interim analysis revealed no significant difference between study groups & increased sample size required to gain significance.)
Effectiveness of OnabotulinumtoxinA (onaBoNT-A) vs Oral Tamsulosin in Men With Benign Prostatic Hyperplasia & Lower Urinary Track Symptoms (#02-10-10-05) [NCT01589263]Phase 263 participants (Actual)Interventional2012-06-01Completed
A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tadalafil on Tamsulosin in Healthy Male Volunteers [NCT02247505]Phase 129 participants (Actual)Interventional2014-09-30Completed
An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers) [NCT02264171]Phase 124 participants (Actual)Interventional2008-04-30Completed
A Single-dose, Randomized, Two-treatment, Two-period, Open-label, Crossover Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride 0.4-mg Capsules in Healthy Male Subjects [NCT02266511]Phase 130 participants (Actual)Interventional1999-08-31Completed
A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in th [NCT00457457]Phase 2609 participants (Actual)Interventional2007-05-31Completed
A Phase 4, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Mirabegron in Japanese and Korean Male Patients With Overactive Bladder Under Treatment With the α-Blocker Tamsulosin for Benign Prostatic Hyp [NCT02656173]Phase 4568 participants (Actual)Interventional2016-01-25Completed
Dutasteride (0.5mg) Once Daily for One Year and Tamsulosin (0.4mg) Once Daily for 3 Months, Followed by Counseling on Flex Dose Tamsulosin as Needed on Improvement of Symptoms and Outcome in Men With Moderate to Severe Symptomatic BPH [NCT00701779]Phase 463 participants (Actual)Interventional2005-09-30Completed
Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial [NCT05032287]235 participants (Actual)Interventional2019-09-01Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once-Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia and Erectile Dysfunc [NCT01937871]Phase 3909 participants (Actual)Interventional2013-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
NCT00090103 (31) [back to overview]Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
NCT00090103 (31) [back to overview]Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
NCT00090103 (31) [back to overview]Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
NCT00090103 (31) [back to overview]The Number of Participants With Each of the Five Components of BPH Clinical Progression
NCT00090103 (31) [back to overview]Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
NCT00090103 (31) [back to overview]Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."
NCT00090103 (31) [back to overview]"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
NCT00090103 (31) [back to overview]Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
NCT00090103 (31) [back to overview]Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
NCT00090103 (31) [back to overview]Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
NCT00090103 (31) [back to overview]Number of Events of Symptom Deterioration at the Indicated Time Periods
NCT00090103 (31) [back to overview]Number of Participants With an Event of Post-baseline BPH-related Hematospermia
NCT00090103 (31) [back to overview]Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
NCT00090103 (31) [back to overview]Number of Participants With AUR or BPH-related Surgery
NCT00090103 (31) [back to overview]Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
NCT00340704 (28) [back to overview]AUCτ ,ss ,DW ,Norm
NCT00340704 (28) [back to overview]Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Vz/F,ss,W,Norm
NCT00340704 (28) [back to overview]λz,ss
NCT00340704 (28) [back to overview]Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover
NCT00340704 (28) [back to overview]RA,Cmax
NCT00340704 (28) [back to overview]t1/2,ss
NCT00340704 (28) [back to overview]Tmax, 1
NCT00340704 (28) [back to overview]Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Tmax,ss
NCT00340704 (28) [back to overview]Change From Baseline in LPP for Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.
NCT00340704 (28) [back to overview]Percent Change From Baseline in LPP for Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Vision Testing for Group D-527.51 Rollover
NCT00340704 (28) [back to overview]Cmax, 1 ,DW ,Norm
NCT00340704 (28) [back to overview]Vision Testing for Group D-Denovo
NCT00340704 (28) [back to overview]Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
NCT00340704 (28) [back to overview]AUCτ,ss
NCT00340704 (28) [back to overview]CL/F,ss,W,Norm
NCT00340704 (28) [back to overview]Cmax,1
NCT00340704 (28) [back to overview]Cmax,ss
NCT00340704 (28) [back to overview]Cmax,ss, DW, Norm
NCT00340704 (28) [back to overview]Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo
NCT00340704 (28) [back to overview]Cmin,ss
NCT00340704 (28) [back to overview]Cpre,ss
NCT00340704 (28) [back to overview]LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover
NCT00340704 (28) [back to overview]MRTpo,ss
NCT00382265 (6) [back to overview]Confirmation of Stone Passage on CT
NCT00382265 (6) [back to overview]Return to Work (if Employed)
NCT00382265 (6) [back to overview]Proportion of Patients Passing Their Stone Within 28 Days by Self Report
NCT00382265 (6) [back to overview]Need for Surgical Intervention
NCT00382265 (6) [back to overview]Crossover to Open Label Tamsulosin
NCT00382265 (6) [back to overview]Any Pain Medication
NCT00448123 (3) [back to overview]Stone Passage
NCT00448123 (3) [back to overview]High Pain Score by Treatment Group
NCT00448123 (3) [back to overview]Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
NCT00507455 (18) [back to overview]Change From Baseline in International Prostate Symptoms Score (IPSS)
NCT00507455 (18) [back to overview]Change From Baseline in IPSS Storage Score
NCT00507455 (18) [back to overview]Change From Baseline in IPSS Voiding Score
NCT00507455 (18) [back to overview]Change From Baseline in Number of Incontinence Episodes Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Number of Micturitions Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Number of Urgency Episodes Per 24 Hours
NCT00507455 (18) [back to overview]Change From Baseline in Patient Perception of Bladder Condition (PPBC)
NCT00507455 (18) [back to overview]Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
NCT00507455 (18) [back to overview]Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
NCT00507455 (18) [back to overview]Change From Baseline in Volume Voided Per Micturition
NCT00507455 (18) [back to overview]Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
NCT00507455 (18) [back to overview]Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
NCT00507455 (18) [back to overview]Change From Baseline in Post Void Residual Volume (PVR)
NCT00507455 (18) [back to overview]Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT00507455 (18) [back to overview]Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary
NCT00540124 (13) [back to overview]Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore
NCT00540124 (13) [back to overview]Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score
NCT00540124 (13) [back to overview]Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore
NCT00540124 (13) [back to overview]Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)
NCT00540124 (13) [back to overview]Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies
NCT00540124 (13) [back to overview]Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)
NCT00540124 (13) [back to overview]Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary
NCT00701779 (9) [back to overview]Benign Prostate Hyperplasia Impact Index
NCT00701779 (9) [back to overview]Economic Impact
NCT00701779 (9) [back to overview]Health Outcome Measures
NCT00701779 (9) [back to overview]International Prostate Symptom Score
NCT00701779 (9) [back to overview]Number of Participants With a Reduction of AUR and BPH-related Surgery
NCT00701779 (9) [back to overview]Peak Flow Rate (QMax)
NCT00701779 (9) [back to overview]Post-void Residual Volume
NCT00701779 (9) [back to overview]Prostate Specific Antigen
NCT00701779 (9) [back to overview]Safety and Tolerability
NCT00796614 (9) [back to overview]Change From Baseline in Urine Volume at Week 14
NCT00796614 (9) [back to overview]Change From Baseline in Number of Times Patient Was Wet at Catheterisation
NCT00796614 (9) [back to overview]Change From Baseline in LPP at Week 14 (End of Treatment)
NCT00796614 (9) [back to overview]Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.
NCT00796614 (9) [back to overview]Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.
NCT00796614 (9) [back to overview]Post Void Residual Volume at Week 14
NCT00796614 (9) [back to overview]Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
NCT00796614 (9) [back to overview]Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline
NCT00796614 (9) [back to overview]Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline
NCT00831701 (5) [back to overview]Time to Stone Passage
NCT00831701 (5) [back to overview]Required Analgesics
NCT00831701 (5) [back to overview]Number of Participants With Stone Expulsion
NCT00831701 (5) [back to overview]Number of Participants Requiring Active Treatment
NCT00831701 (5) [back to overview]Maximum Daily Pain Score
NCT00861757 (12) [back to overview]Change From Baseline in Blood Pressure (Standing) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in Blood Pressure (Sitting) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
NCT00861757 (12) [back to overview]Clinician Global Impression of Improvement (CGI-I) at Week 12
NCT00861757 (12) [back to overview]Patient Global Impression of Improvement (PGI-I) at Week 12
NCT00861757 (12) [back to overview]Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks
NCT00861757 (12) [back to overview]Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks
NCT00970632 (17) [back to overview]Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall
NCT00970632 (17) [back to overview]Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
NCT00970632 (17) [back to overview]Patient Global Impression of Improvement (PGI-I) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
NCT00970632 (17) [back to overview]Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week
NCT00970632 (17) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks
NCT00970632 (17) [back to overview]Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
NCT01018511 (44) [back to overview]Maximum Concentration at Steady State (Cmaxss) of Tamsulosin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Self-care Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Mobility Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
NCT01018511 (44) [back to overview]AUCss of Solifenacin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
NCT01018511 (44) [back to overview]Tmaxss of Solifenacin
NCT01018511 (44) [back to overview]Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin
NCT01018511 (44) [back to overview]Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms
NCT01018511 (44) [back to overview]Patient Global Impression Scale at End of Treatment: General Health
NCT01018511 (44) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01018511 (44) [back to overview]Minimum Concentration at Steady State (Cminss) of Tamsulosin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Symptom Bother Score
NCT01018511 (44) [back to overview]Cminss of Solifenacin
NCT01018511 (44) [back to overview]Cmaxss of Solifenacin
NCT01018511 (44) [back to overview]Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms
NCT01018511 (44) [back to overview]CL/F of Solifenacin
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Individual IPSS Scores
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS Voiding Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS Storage Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in IPSS QoL Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Total Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in HRQoL Subscale: Social Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Total International Prostate Symptom Score
NCT01018511 (44) [back to overview]Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])
NCT01018511 (44) [back to overview]Percentage of Participants Who Were OAB-q Responders at End of Treatment
NCT01018511 (44) [back to overview]Apparent Clearance (CL/F) of Tamsulosin
NCT01018511 (44) [back to overview]Area Under the Curve at Steady State (AUCss) of Tamsulosin
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Storage Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in IPSS Voiding Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Individual IPSS Scores
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Self-care Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Mobility Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
NCT01021332 (31) [back to overview]Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Symptom Bother Score
NCT01021332 (31) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score
NCT01021332 (31) [back to overview]Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
NCT01028014 (3) [back to overview]Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
NCT01149733 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01149733 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01149733 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01175382 (18) [back to overview]Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01175382 (18) [back to overview]Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)
NCT01294592 (11) [back to overview]Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
NCT01294592 (11) [back to overview]Exposure to Study Drug
NCT01294592 (11) [back to overview]Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization
NCT01294592 (11) [back to overview]Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
NCT01294592 (11) [back to overview]Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH
NCT01294592 (11) [back to overview]Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
NCT01294592 (11) [back to overview]Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
NCT01294592 (11) [back to overview]Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach
NCT01294592 (11) [back to overview]Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries
NCT01294592 (11) [back to overview]Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
NCT01294592 (11) [back to overview]Number of Events of Clinical Progression (CP) of BPH
NCT01457573 (11) [back to overview]Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.
NCT01457573 (11) [back to overview]Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)
NCT01457573 (11) [back to overview]Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12
NCT01457573 (11) [back to overview]Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
NCT01457573 (11) [back to overview]Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.
NCT01457573 (11) [back to overview]Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8
NCT01533597 (6) [back to overview]Change in Total Score of OABSS
NCT01533597 (6) [back to overview]Change of PVR
NCT01533597 (6) [back to overview]Numeric Change of Urgency Episodes Per 24 Hours
NCT01533597 (6) [back to overview]Change of Qmax
NCT01533597 (6) [back to overview]Change in Mean Number of Micturition Episodes Per 24 Hours
NCT01533597 (6) [back to overview]Change in Score of IPSS
NCT01534351 (2) [back to overview]Number of Participants Who Discontinued Treatment Due to an Adverse Event
NCT01534351 (2) [back to overview]Number of Participants Who Experienced an Adverse Event
NCT01589263 (1) [back to overview]American Urologic Association Symptom Score (AUASS)
NCT01673490 (10) [back to overview]Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
NCT01673490 (10) [back to overview]Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
NCT01673490 (10) [back to overview]Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
NCT01673490 (10) [back to overview]Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
NCT01673490 (10) [back to overview]Free to Total PSA Ratio at the Indicated Time Points
NCT01673490 (10) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
NCT01673490 (10) [back to overview]Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
NCT01673490 (10) [back to overview]Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
NCT01673490 (10) [back to overview]Number Participants With a Negative or Positive Response at the Indicated Time Points
NCT01673490 (10) [back to overview]Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
NCT01726270 (6) [back to overview]Percentage of Participants Who Took no More Than One Capsule Per Day
NCT01726270 (6) [back to overview]Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
NCT01726270 (6) [back to overview]Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
NCT01726270 (6) [back to overview]Percentage of Participants Who Appropriately Followed the Label Instructions
NCT01726270 (6) [back to overview]Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
NCT01726270 (6) [back to overview]"Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day"
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
NCT01741454 (4) [back to overview]Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
NCT01777269 (11) [back to overview]Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
NCT01777269 (11) [back to overview]Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
NCT01777269 (11) [back to overview]Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
NCT01777269 (11) [back to overview]Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
NCT01777269 (11) [back to overview]Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
NCT01937871 (22) [back to overview]Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IIEF Intercourse Satisfaction at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IIEF Orgasmic Function at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IIEF Sexual Desire at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IPSS at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2
NCT01937871 (22) [back to overview]Change From Baseline in Postvoid Residual Volume (PVR) at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Uroflowmetry Measures at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in IIEF EF at Week 4 and Week 8
NCT01937871 (22) [back to overview]Change From Baseline in IIEF Subscores at Week 12
NCT01937871 (22) [back to overview]Change From Baseline in Total IPSS at Week 4 and Week 8
NCT01937871 (22) [back to overview]Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8
NCT01937871 (22) [back to overview]Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8
NCT01937871 (22) [back to overview]Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12
NCT02058368 (23) [back to overview]Number of Participants With Digital Rectal Examination (DRE)
NCT02058368 (23) [back to overview]Number of Participants With Hospital Admissions
NCT02058368 (23) [back to overview]Number of Subjects With AUR
NCT02058368 (23) [back to overview]Percent Change in Prostate Volume From Baseline
NCT02058368 (23) [back to overview]Number of Participants With IPSS Improvement From Baseline
NCT02058368 (23) [back to overview]Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)
NCT02058368 (23) [back to overview]Number of Participants With Qmax Improvement From Baseline by LOCF Approach.
NCT02058368 (23) [back to overview]Number of Participants With Suicidal Ideation and Suicidal Behavior
NCT02058368 (23) [back to overview]Number of Participants With Threshold Clinical Chemistry Value.
NCT02058368 (23) [back to overview]Number of Participants With Threshold Hematology Value.
NCT02058368 (23) [back to overview]Number of Participants With Vital Signs Exceeding Threshold Values
NCT02058368 (23) [back to overview]Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)
NCT02058368 (23) [back to overview]Change From Baseline in Serum Prostate Specific Antigen (PSA)
NCT02058368 (23) [back to overview]Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery
NCT02058368 (23) [back to overview]Number of Participants With BPH-related Surgery
NCT02058368 (23) [back to overview]Number of Participants With Clinically Significant Qualitative Breast Examination
NCT02058368 (23) [back to overview]Number of Hospitalization Days
NCT02058368 (23) [back to overview]Change From Baseline in BPH Impact Index (BII) by LOCF Approach
NCT02058368 (23) [back to overview]Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months
NCT02058368 (23) [back to overview]Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach
NCT02058368 (23) [back to overview]Number of Participants in a Hospital Ward
NCT02058368 (23) [back to overview]Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach
NCT02058368 (23) [back to overview]Change From Baseline in Post Void Residual Volume
NCT02417831 (6) [back to overview]λz
NCT02417831 (6) [back to overview](AUC0-inf)
NCT02417831 (6) [back to overview]AUC0-tz
NCT02417831 (6) [back to overview]Cmax
NCT02417831 (6) [back to overview]t1/2
NCT02417831 (6) [back to overview]Tmax
NCT02417844 (6) [back to overview]Terminal Elimination Rate Constant (λz)
NCT02417844 (6) [back to overview]Maximum Measured Concentration (Cmax)
NCT02417844 (6) [back to overview]Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
NCT02417844 (6) [back to overview]Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
NCT02417844 (6) [back to overview]Apparent Terminal Elimination Half-life (t1/2)
NCT02417844 (6) [back to overview]Time to Maximum Plasma Concentration (Tmax)
NCT02486653 (8) [back to overview]First Post-void Residual Urine Volume
NCT02486653 (8) [back to overview]Hospital Length of Stay in Days
NCT02486653 (8) [back to overview]Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
NCT02486653 (8) [back to overview]Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
NCT02486653 (8) [back to overview]Number of Participants Who Experienced Adverse Events
NCT02486653 (8) [back to overview]Total Number of Intermittent Catheterizations Required Per Subject
NCT02486653 (8) [back to overview]Urinary Tract Infection (UTI)
NCT02486653 (8) [back to overview]Discharge From Hospital With Indwelling Urinary Catheter
NCT02518971 (6) [back to overview]Incidence of Postoperative Complications
NCT02518971 (6) [back to overview]Acute Postoperative Pain Medication Dosages
NCT02518971 (6) [back to overview]Incidence of Discharge to a Skilled Nursing Facility
NCT02518971 (6) [back to overview]Incidence of Surgical Site Infection
NCT02518971 (6) [back to overview]Length of Hospital Stay
NCT02518971 (6) [back to overview]Number of Patients to Develop Postoperative Urinary Retention (POUR)
NCT02573311 (9) [back to overview]Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
NCT02573311 (9) [back to overview]"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1"
NCT02573311 (9) [back to overview]"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1"
NCT02573311 (9) [back to overview]"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1"
NCT02573311 (9) [back to overview]"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks"
NCT02573311 (9) [back to overview]"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1"
NCT02573311 (9) [back to overview]Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
NCT02573311 (9) [back to overview]"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks"
NCT02573311 (9) [back to overview]"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition"
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Nocturia Episodes
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Mean Volume Voided Per Micturition
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Postvoid Residual (PVR) Volume
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)
NCT02656173 (16) [back to overview]Change From Baseline to EoT in IPSS Subscale Scores
NCT02656173 (16) [back to overview]Change From Baseline to EoT in OABSS Subscale Scores
NCT02656173 (16) [back to overview]Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours
NCT02656173 (16) [back to overview]Number of Participants With Adverse Events
NCT02656173 (16) [back to overview]Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)
NCT02656173 (16) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours
NCT02684344 (1) [back to overview]Number of Participants With Post-operative Urinary Retention
NCT02757768 (21) [back to overview]Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score
NCT02757768 (21) [back to overview]Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day
NCT02919436 (2) [back to overview]Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention
NCT02919436 (2) [back to overview]Length of Stay
NCT03524339 (4) [back to overview]International Prostate Symptom Score
NCT03524339 (4) [back to overview]Sent Home With Catheterization
NCT03524339 (4) [back to overview]Postoperative Urinary Tract Infection
NCT03524339 (4) [back to overview]Postoperative Urinary Retention

Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=908, 932, 889BL, Neutral/Any Dissatisfact., n=908, 932, 889Month (M) 12, Any Satisfact., n=1022, 1088, 1019M12, Neutral/Any Dissatisfact., n=1022, 1088, 1019M24, Any Satisfact., n=1077, 1151, 1085M24, Neutral/Any Dissatisfact., n=1077, 1151, 1085M36, Any Satisfact., n=1115, 1200, 1135M36, Neutral/Any Dissatisfact., n=1115, 1200, 1135M48, Any Satisfact., n=1135, 1223, 1161M48, Neutral/Any Dissatisfact., n=1135, 1223, 1161
Dutasteride 0.5 mg351581672416740411785415792431
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg375533712310764313799316810325
Tamsulosin 0.4 mg351538681338708377736399739422

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Improvement, n=1585, 1600, 1586BL, No Change/Any Worsening, n=1585, 1600, 1586Month (M) 12, Any Improvement, n=1576, 1593, 1581M12, No Change/Any Worsening, n=1576, 1593, 1581M24, Any Improvement, n=1576, 1593, 1581M24, No Change/Any Worsening, n=1576, 1593, 1581M36, Any Improvement, n=1576, 1593, 1581M36, No Change/Any Worsening, n=1576, 1593, 1581M48, Any Improvement, n=1576, 1593, 1581M48, No Change/Any Worsening, n=1576, 1593, 1581
Dutasteride 0.5 mg6569441171422120039312033901212381
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg6968891281295127330312683081278298
Tamsulosin 0.4 mg7068801218363119538611524291138443

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=1574, 1600, 1576BL, Neutral /Any Dissatisfact., n=1574, 1600, 1576Month (M) 12, Any Satisfact., n=1575, 1593, 1580M12, Neutral/Any Dissatisfact., n=1575, 1593, 1580M24, Any Satisfact., n=1575, 1593, 1580M24, Neutral/Any Dissatisfact., n=1575, 1593, 1580M36, Any Satisfact., n=1575, 1593, 1580M36, Neutral/Any Dissatisfact., n=1575, 1593, 1580M48, Any Satisfact., n=1575, 1593, 1580M48, Neutral/Any Dissatisfact., n=1575, 1593, 1580
Dutasteride 0.5 mg56510351073520111647710984951123470
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg6119631176399120537012103651213362
Tamsulosin 0.4 mg5849921114466108849210745061043537

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=1573, 1598, 1574BL, Neutral/Any Dissatisfact., n=1573, 1598, 1574Month (M) 12, Any Satisfact., n=1574, 1592, 1581M12, Neutral/Any Dissatisfact., n=1574, 1592, 1581M24, Any Satisfact., n=1574, 1592, 1581M24, Neutral/Any Dissatisfact., n=1574, 1592, 1581M36, Any Satisfact., n=1574, 1592, 1581M36, Neutral/Any Dissatisfact., n=1574, 1592, 1581M48, Any Satifact., n=1574, 1592, 1581M48, Neutral/Any Dissatisfact., n=1574, 1592, 1581
Dutasteride 0.5 mg6839151159433118840411884041182410
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg717856150324127929512703041262312
Tamsulosin 0.4 mg6998751202379116341811194621097484

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline, Yes, n=1560, 1579, 1562Baseline, No/Not Sure, n=1560, 1579, 1562Month 12, Yes, n=1574, 1592, 1581Month 12, No/Not Sure, n=1574, 1592, 1581Month 24, Yes, n=1574, 1592, 1581Month 24, No/Not Sure, n=1574, 1592, 1581Month 36, Yes, n=1574, 1592, 1581Month 36, No/Not Sure, n=1574, 1592, 1581Month 48, Yes, n=1574, 1592, 1581Month 48, No/Not Sure, n=1574, 1592, 1581
Dutasteride 0.5 mg5571022920671955636956636918674
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg587973972602102754710315431003571
Tamsulosin 0.4 mg582980970611952629915666874707

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=1587, 1600, 1583BL, Neutral/Any Dissatisfact., n=1587, 1600, 1583Month (M) 12, Any Satisfact., n=1576, 1593, 1581M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581M24, Any Satisfact., n=1576, 1593, 1581M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581M36, Any Satisfact., n=1576, 1593, 1581M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581M48, Any Satisfact., n=1576, 1593, 1581M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581
Dutasteride 0.5 mg6529481127466116642711674261172421
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg7078801224352126131512603161267309
Tamsulosin 0.4 mg6868971178403115043111204611088493

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Improvement, n=1585, 1601, 1585BL, No Change/Any Worsening, n=1585, 1601, 1585Month (M) 12, Any Improvement, n=1576, 1593, 158M12, No Change/Any Worsening, n=1576, 1593, 1581M24, Any Improvement, n=1576, 1593, 1581M24, No Change/Any Worsening, n=1576, 1593, 1581M36, Any Improvement, n=1576, 1593, 1581M36, No Change/Any Worsening, n=1576, 1593, 1581M48, Any Improvement, n=1576, 1593, 1581M48, No Change/Any Worsening, n=1576, 1593, 1581
Dutasteride 0.5 mg6029991044549107052310715221086507
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg6299561181395121536112063701202374
Tamsulosin 0.4 mg6159701105476105752410235581008573

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=1583,1601,1582BL, Neutral/Any Dissatisfact., n=1583,1601,1582Month (M) 12, Any Satisfact., n=1576, 1593, 1581M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581M24, Any Satisfact., n=1576, 1593, 1581M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581M36, Any Satisfact., n=1576, 1593, 1581M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581M48, Any Satisfact., n=1576, 1593, 1581M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581
Dutasteride 0.5 mg58610151037556107252110755181089504
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg6329511154422120337312013751208368
Tamsulosin 0.4 mg6139691097484105153010395421022559

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Improvement, n=869, 901, 849BL, No Change/Any Worsening, n=869, 901, 849Month (M) 12, Any Improvement, n=769, 817, 771M12, No Change/Any Worsening, n=769, 817, 771M24, Any Improvement, n=720, 780, 771M24, No Change/Any Worsening, n=720, 780, 771M36, Any Improvement, n=714, 753, 748M36, No Change/Any Worsening, n=714, 753, 748M48, Any Improvement, n=709, 756, 751M48, No Change/Any Worsening, n=709, 756, 751
Dutasteride 0.5 mg331570526291526254514239510246
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg337532556213537183540174531178
Tamsulosin 0.4 mg332517527244535236496252489262

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Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was yes, the number of visits was recorded." (NCT00090103)
Timeframe: Every 3 months from Month 3 to Month 48

,,
Interventionvisits (Number)
Month 3, n=1550, 1581, 1564Month 6, n=1479, 1516, 1514Month 9, n=1439, 1465, 1477Month 12, n=1400, 1431, 1434Month 15, n=1343, 1386, 1381Month 18, n=1318, 1350, 1328Month 21, n=1281, 1326, 1287Month 24, n=1263, 1293, 1244Month 27, n=1233, 1262, 1206Month 30, n=1222, 1221, 1166Month 33, n=1202, 1199, 1128Month 36, n=1187, 1174, 1095Month 39, n=1160, 1144, 1055Month 42, n=1149, 1126, 1035Month 45, n=1129, 1110, 1009Month 48, n=1113, 1093, 990
Dutasteride 0.5 mg27292728282127231216131210974
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg2723123019232029131068121557
Tamsulosin 0.4 mg303326293234262616102018181588

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Improvement, n=852, 889, 822BL, No Change/Any Worsening, n=852, 889, 822Month (M) 12, Any Improvement, n=760, 781, 755M12, No Change/Any Worsening, n=760, 781, 755M24, Any Improvement, n=706, 760, 747M24, No Change/Any Worsening, n=706, 760, 747M36, Any Improvement, n=704, 741, 733M36, No Change/Any Worsening, n=704, 741, 733M48, No Change/Any Worsening, n=702, 739, 740M48, Any Improvement, n=702, 739, 740
Dutasteride 0.5 mg314575500281508252504237252487
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg321531550210532174529175175527
Tamsulosin 0.4 mg319503529226519228491242257483

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Satisfact., n=890, 925, 851BL, Neutral/Any Dissatisfact., n=890, 925, 851Month (M) 12, Any Satisfact., n=1022, 1088, 1011M12, Neutral/Any Dissatisfact., n=1022, 1088, 1011M24, Any Satisfact., n=1077, 1155, 1079M24, Neutral/Any Dissatisfact., n=1077, 1155, 1079M36, Any Satisfact., n=1121, 1206, 1131M36, Neutral/Any Dissatisfact., n=1121, 1206, 1131M48, Any Satsifact., n=1146,1224,1160M48, Neutral/Any Dissatisfact., n=1146, 1224, 1160
Dutasteride 0.5 mg348577655433730425784422785439
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg354536712310763314807314827319
Tamsulosin 0.4 mg333518678333708371724407729431

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Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)

"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?." (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionparticipants (Number)
Baseline (BL), Any Improvement, n=1574, 1599, 1575BL, No Change/Any Worsening, n=1574, 1599, 1575Month (M) 12, Any Improvement, n=1575, 1593, 1580M12, No Change/Any Worsening, n=1575, 1593, 1580M24, Any Improvement, n=1575, 1593, 1580M24, No Change/Any Worsening, n=1575, 1593, 1580M36, Any Improvement, n=1575, 1593, 1580M36, No Change/Any Worsening, n=1575, 1593, 1580M48, Any Improvement, n=1575, 1593, 1580M48, No Change/Any Worsening, n=1575, 1593, 1580
Dutasteride 0.5 mg48111181027566105354015935291063530
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg50910651124451114642915754121148427
Tamsulosin 0.4 mg49410811084496104953115805531008572

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The Number of Participants With Each of the Five Components of BPH Clinical Progression

The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency. (NCT00090103)
Timeframe: Baseline (Day 1) to Year 4

,,
Interventionparticipants (Number)
Symptom deteriorationBPH-related AURBPH-related incontinenceRecurrent BPH-related UTIBPH-related renal insufficiency
Dutasteride 0.5 mg203314952
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg132224621
Tamsulosin 0.4 mg221645635

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Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit

"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was yes, the number of visits was recorded." (NCT00090103)
Timeframe: Every 3 months from Month 3 to Month 48

,,
Interventionvisits (Number)
Month 3, n=1550, 1581, 1565Month 6, n=1479, 1517, 1514Month 9, n=1439, 1465, 1477Month 12, n=1400, 1431, 1434Month 15, n=1343, 1386, 1380Month 18, n=1318, 1350, 1328Month 21, n=1281, 1326, 1287Month 24, n=1263, 1293, 1244Month 27, n=1233, 1262, 1206Month 30, n=1222, 1221, 1166Month 33, n=1202, 1199, 1128Month 36, n=1187, 1174, 1095Month 39, n=1160, 1144, 1055Month 42, n=1149, 1126, 1035Month 45, n=1129, 1110, 1009Month 48, n=1113, 1093, 990
Dutasteride 0.5 mg6433643262412222
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg8243333213322311
Tamsulosin 0.4 mg73896109778555842

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Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48

The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS. (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionpoints on a scale (Least Squares Mean)
Month 12Month 24Month 36Month 48
Dutasteride 0.5 mg-4.2-4.9-5.2-5.3
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-5.6-6.2-6.3-6.3
Tamsulosin 0.4 mg-4.5-4.3-4.0-3.8

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"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."

"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was yes, the number of Yes responses was recorded." (NCT00090103)
Timeframe: Every 3 months from Month 3 to Month 48

,,
Interventionyes responses (Number)
Month 3, n=1550, 1581, 1564Month 6, n=1479, 1516, 1513Month 9, n=1439, 1465, 1477Month 12, n=1400, 1431, 1434Month 15, n=1343, 1386, 1380Month 18, n=1318, 1350, 1328Month 21, n=1281, 1326, 1287Month 24, n=1263, 1293, 1244Month 27, n=1233, 1262, 1206Month 30, n=1222, 1221, 1166Month 33, n=1202, 1199, 1128Month 36, n=1187, 1174, 1095Month 39, n=1160, 1144, 1055Month 42, n=1149, 1126, 1035Month 45, n=1129, 1110, 1009Month 48, n=1113, 1093, 990
Dutasteride 0.5 mg3226141315131591191049889
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg312118891710597957672
Tamsulosin 0.4 mg29261891219178891156855

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"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"

"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of Yes responses was recorded." (NCT00090103)
Timeframe: Every 3 months from Month 3 to Month 48

,,
Interventionyes responses (Number)
Month 3, n=1550, 1581, 1564Month 6, n=1479, 1516, 1513Month 9, n=1438, 1465, 1477Month 12, n=1400, 1431, 1434Month 15, n=1343, 1386, 1380Month 18, n=1318, 1350, 1328Month 21, n=1281, 1326, 1287Month 24, n=1263, 1293, 1244Month 27, n=1233, 1262, 1206Month 30, n=1222, 1221, 1166Month 33, n=1202, 1199, 1128Month 36, n=1187, 1174, 1095Month 39, n=1160, 1144, 1055Month 42, n=1149, 1126, 1034Month 45, n=1129, 1110, 1009Month 48, n=1113, 1093, 990
Dutasteride 0.5 mg342310109129799758883
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg162012591310497537961
Tamsulosin 0.4 mg28161769108354825251

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Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48

The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII. (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

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Interventionpoints on a scale (Least Squares Mean)
Month 12Month 24Month 36Month 48
Dutasteride 0.5 mg-1.5-1.7-1.8-1.8
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-1.9-2.1-2.2-2.2
Tamsulosin 0.4 mg-1.6-1.5-1.3-1.2

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Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48

Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL. (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

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Interventionpercent change (Least Squares Mean)
Month 12, n= 150, 159, 160Month 24, n= 153, 164, 160Month 36, n= 155, 164, 162Month 48, n= 155, 164, 163
Dutasteride 0.5 mg-15.6-22.8-26.7-26.5
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-17.2-23.4-20.9-17.9
Tamsulosin 0.4 mg5.68.714.718.2

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Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48

Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax. (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionmilliliters (mL)/second (sec) (Least Squares Mean)
Month 12, n=1477, 1482, 1510Month 24, n= 1492, 1501, 1519Month 36, n= 1495, 1504, 1521Month 48, n= 1495, 1505, 1523
Dutasteride 0.5 mg1.51.91.92.0
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg2.02.42.62.4
Tamsulosin 0.4 mg0.90.90.60.7

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Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48

Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline. (NCT00090103)
Timeframe: Baseline and Months 12, 24, 36, and 48

,,
Interventionpercent change (Least Squares Mean)
Month 12, n=1411, 1442, 1451Month 24, n= 1427, 1451, 1465Month 36, n= 1430, 1455, 1468Month 48, n= 1430, 1455, 1468
Dutasteride 0.5 mg-25.2-28.0-28.8-28.0
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-24.1-26.9-27.6-27.3
Tamsulosin 0.4 mg-1.50.01.64.6

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Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4

The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond. (NCT00090103)
Timeframe: Years 1, 2, 3, and 4

,,
Interventionevents (Number)
Year 1, n=1610, 1623, 1611Year 2, n= 1264, 1240, 1262Year 3, n=1135, 1082, 1048Year 4, n= 1047, 959, 880
Dutasteride 0.5 mg184542922
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg126313016
Tamsulosin 0.4 mg171786731

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Number of Events of Symptom Deterioration at the Indicated Time Periods

The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35). (NCT00090103)
Timeframe: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)

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Interventionevents (Number)
Year 1, n=1610, 1623, 1611Year 2, n=1286, 1278, 1296Year 3, n=1158, 1132, 1088Year 4, n=1083, 1001, 926
Dutasteride 0.5 mg138382313
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg91231411
Tamsulosin 0.4 mg119494219

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Number of Participants With an Event of Post-baseline BPH-related Hematospermia

A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories. (NCT00090103)
Timeframe: Baseline (Day 1) through Year 4

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Interventionparticipants (Number)
Overall Crude RateNon-BPH-related Crude RateBPH-related Crude Rate
Dutasteride 0.5 mg19317
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg18217
Tamsulosin 0.4 mg20911

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Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria

A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories. (NCT00090103)
Timeframe: Baseline (Day 1) through Year 4

,,
Interventionparticipants (Number)
Overall crude rateNon-BPH-related Crude RateBPH-Related Crude Rate
Dutasteride 0.5 mg702845
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg531540
Tamsulosin 0.4 mg812556

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Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was yes, the number of visits was recorded." (NCT00090103)
Timeframe: Every 3 months from Month 3 to Month 48

,,
Interventionvisits (Number)
Month 3, n=1550, 1581, 1564Month 6, n=1479, 1517, 1514Month 9, n=1439, 1465, 1477Month 12, n=1400, 1431, 1434Month 15, n=1343, 1386, 1380Month 18, n=1318, 1350, 1328Month 21, n=1281, 1326, 1287Month 24, n=1263, 1293, 1244Month 27, n=1233, 1262, 1206Month 30, n=1222, 1221, 1166Month 33, n=1202, 1199, 1128Month 36, n=1187, 1174, 1095Month 39, n=1160, 1144, 1055Month 42, n=1149, 1126, 1035Month 45, n=1129, 1110, 1009Month 48, n=1113, 1093, 990
Dutasteride 0.5 mg25343529222521191185413856
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg2323163024211810157456431
Tamsulosin 0.4 mg26222234272614211410107191265

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AUCτ ,ss ,DW ,Norm

Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng*h/mL/mg*kg (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)26100
Tamsulosin - Medium Dose Level (Steady State - PK Study)25200
Tamsulosin - High Dose Level (Steady State - PK Study)27700

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Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover

Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided. (NCT00340704)
Timeframe: From first drug administration until 28 days after last study drug administration, upto 395 days

InterventionParticipants (Number)
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)1
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)0
Tamsulosin - High Dose Level (Group D-527.51 Rollover)0

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Vz/F,ss,W,Norm

Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

InterventionL/kg (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)0.65
Tamsulosin - Medium Dose Level (Steady State - PK Study)0.591
Tamsulosin - High Dose Level (Steady State - PK Study)0.729

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λz,ss

Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Intervention1/hours (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)0.0589
Tamsulosin - Medium Dose Level (Steady State - PK Study)0.0671
Tamsulosin - High Dose Level (Steady State - PK Study)0.0496

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Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover

Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided. (NCT00340704)
Timeframe: Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.

Interventionpercentage of responders (Number)
Tamsulosin - Low Dose Level (Group D-Denovo)73.1
Tamsulosin - Medium Dose Level (Group D-Denovo)35.7
Tamsulosin - High Dose Level (Group D-Denovo)26.7
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)67.9
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)58.3
Tamsulosin - High Dose Level (Group D-527.51 Rollover)20.7

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RA,Cmax

The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

InterventionRatio (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)1.58

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t1/2,ss

Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionhours (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)11.80
Tamsulosin - Medium Dose Level (Steady State - PK Study)10.30
Tamsulosin - High Dose Level (Steady State - PK Study)14.00

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Tmax, 1

Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.

Interventionhours (Median)
PK Study - Single Dose6

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Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover

Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided. (NCT00340704)
Timeframe: Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).

InterventionParticipants (Number)
Tamsulosin-low Dose Level (Group D-Denovo)17
Tamsulosin-medium Dose Level (Group D-Denovo)5
Tamsulosin - High Dose Level (Group D-Denovo)3

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Tmax,ss

Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionhours (Median)
Tamsulosin - Low Dose Level (Steady State - PK Study)5.00
Tamsulosin - Medium Dose Level (Steady State - PK Study)5.92
Tamsulosin - High Dose Level (Steady State - PK Study)5.01

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Change From Baseline in LPP for Group D-527.51 Rollover

Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided. (NCT00340704)
Timeframe: Baseline and week 1

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Interventioncm H2O (Median)
Baseline (N= 53 (LD), 12 (MD), 29(HD))Week 1 - Actual (N= 39 (LD), 9 (MD),22 (HD))Week 1 - Change (N= 39 (LD), 9 (MD),22 (HD))
Tamsulosin - High Dose Level (Group D-527.51 Rollover)55.5064.75-1.25
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)48.5029.00-25.5
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)48.549.50-2

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Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.

Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided. (NCT00340704)
Timeframe: Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.

,,
InterventionParticipants (Number)
Week 1 (N= 40 (LD), 12 (MD), 27 (HD))Week 2 (N= 2 (LD), 7 (MD), 27 (HD))Week 3 (N= 3 (LD), 0 (MD), 22 (HD))Week 4 (N= 1 (LD), 0 (MD), 3 (HD))Week 9 (N= 7 (LD), 2 (MD), 16 (HD))Week 13 (N= 4 (LD), 0 (MD), 2 (HD))Week 26 (N= 2 (LD), 0 (MD), 3 (HD))Week 52 (N= 1 (LD), 1 (MD), 0 (HD))
Tamsulosin - High Dose Level (Group D-527.51 Rollover)02505110
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)382215111
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)17002001

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Percent Change From Baseline in LPP for Group D-527.51 Rollover

Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided. (NCT00340704)
Timeframe: Baseline and Week 1

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Interventionpercent change (Median)
Baseline (N= 53 (LD), 12 (MD), 29 (HD))Week 1 - Actual (N= 39 (LD), 9 (MD), 22 (HD))Week 1 - Change (N= 39 (LD), 9 (MD), 22 (HD))
Tamsulosin - High Dose Level (Group D-527.51 Rollover)55.5064.75-2.71
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)48.5029.00-48.48
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)48.5049.50-3.88

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Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover

Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization. (NCT00340704)
Timeframe: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.

,,,,,
InterventionParticipants (Number)
Right KidneyLeft Kidney
Tamsulosin - High Dose Level (Group D-527.51 Rollover)1717
Tamsulosin - High Dose Level (Group D-Denovo)2826
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)3942
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)87
Tamsulosin-low Dose Level (Group D-Denovo)2624
Tamsulosin-medium Dose Level (Group D-Denovo)1514

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Vision Testing for Group D-527.51 Rollover

Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided. (NCT00340704)
Timeframe: Baseline and Week 52

,,
InterventionParticipants (Number)
Right Eye - No ChangeRight Eye - Decrease in visual acuityRight Eye - Increase in visual acuityRight Eye - MissingLeft Eye - No ChangeLeft Eye - Decrease in visual acuityLeft Eye - Increase in visual acuityLeft Eye - Missing
Tamsulosin - High Dose Level (Group D-527.51 Rollover)1246712377
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)325125318105
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)1021012100

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Cmax, 1 ,DW ,Norm

Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.

Interventionng/mL/mg*kg (Geometric Mean)
PK Study - Single Dose1120

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Vision Testing for Group D-Denovo

Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided. (NCT00340704)
Timeframe: Baseline, Week 26 and Week 52.

,,
InterventionParticipants (Number)
Right Eye (Week 26) - No ChangeRight Eye (Week 26) - Decrease in visual acuityRight Eye (Week 26) - Increase in visual acuityRight Eye (Week 26) - MissingLeft Eye (Week 26) - No ChangeLeft Eye (Week 26) - Decrease in visual acuityLeft Eye (Week 26) - Increase in visual acuityLeft Eye (Week 26) - MissingRight Eye (Week 52) - No ChangeRight Eye (Week 52) - Decrease in visual acuityRight Eye (Week 52) - Increase in visual acuityRight Eye (Week 52) - MissingLeft Eye (Week 52) - No ChangeLeft Eye (Week 52) - Decrease in visual acuityLeft Eye (Week 52) - Increase in visual acuityLeft Eye (Week 52) - Missing
Tamsulosin - High Dose Level (Group D-Denovo)12811619486164125126145
Tamsulosin - Low Dose Level (Group D-Denovo)1188211792710111116111
Tamsulosin - Medium Dose Level (Group D-Denovo)7149615962675376

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Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover

Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided. (NCT00340704)
Timeframe: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.

,,,,,
InterventionParticipants (Number)
Right KidneyLeft Kidney
Tamsulosin - High Dose Level (Group D-527.51 Rollover)1917
Tamsulosin - High Dose Level (Group D-Denovo)2829
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)4343
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)88
Tamsulosin-low Dose Level (Group D-Denovo)2624
Tamsulosin-medium Dose Level (Group D-Denovo)1514

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AUCτ,ss

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng*h/mL (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)35.80
Tamsulosin - Medium Dose Level (Steady State - PK Study)68.20
Tamsulosin - High Dose Level (Steady State - PK Study)175.00

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CL/F,ss,W,Norm

Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

InterventionL/h/kg (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)0.0383
Tamsulosin - Medium Dose Level (Steady State - PK Study)0.0397
Tamsulosin - High Dose Level (Steady State - PK Study)0.0361

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Cmax,1

Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.

Interventionng/mL (Geometric Mean)
PK Study - Single Dose1.67

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Cmax,ss

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng/mL (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)2.79
Tamsulosin - Medium Dose Level (Steady State - PK Study)5.02
Tamsulosin - High Dose Level (Steady State - PK Study)14.10

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Cmax,ss, DW, Norm

Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng/mL/mg*kg (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)2040
Tamsulosin - Medium Dose Level (Steady State - PK Study)1850
Tamsulosin - High Dose Level (Steady State - PK Study)2240

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Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo

Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided. (NCT00340704)
Timeframe: From first drug administration until 28 days after last study drug administration, upto 450 days

,,
InterventionParticipants (Number)
Blood urine presentBody temperature increasedOrthostatic hypotension
Tamsulosin - High Dose Level (Group D-Denovo)110
Tamsulosin - Low Dose Level (Group D-Denovo)001
Tamsulosin - Medium Dose Level (Group D-Denovo)003

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Cmin,ss

Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng/mL (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)0.747
Tamsulosin - Medium Dose Level (Steady State - PK Study)1.52
Tamsulosin - High Dose Level (Steady State - PK Study)4.01

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Cpre,ss

Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionng/mL (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)0.914
Tamsulosin - Medium Dose Level (Steady State - PK Study)1.83
Tamsulosin - High Dose Level (Steady State - PK Study)4.03

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LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover

Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided. (NCT00340704)
Timeframe: Week 1 to Week 52 (described study wise in the Description).

Interventionparticipants (Number)
Tamsulosin-low Dose Level (Group D-Denovo)26
Tamsulosin-medium Dose Level (Group D-Denovo)16
Tamsulosin - High Dose Level (Group D-Denovo)16
Tamsulosin - Low Dose Level (Group D-527.51 Rollover)42
Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)8
Tamsulosin - High Dose Level (Group D-527.51 Rollover)12

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MRTpo,ss

Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided. (NCT00340704)
Timeframe: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.

Interventionhours (Geometric Mean)
Tamsulosin - Low Dose Level (Steady State - PK Study)18.70
Tamsulosin - Medium Dose Level (Steady State - PK Study)17.60
Tamsulosin - High Dose Level (Steady State - PK Study)20.90

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Confirmation of Stone Passage on CT

(NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin102
Placebo90

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Return to Work (if Employed)

(NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin202
Control Group185

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Proportion of Patients Passing Their Stone Within 28 Days by Self Report

Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days. (NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin128
Placebo113

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Need for Surgical Intervention

(NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin14
Placebo13

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Crossover to Open Label Tamsulosin

(NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin15
Placebo14

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Any Pain Medication

Patients on any pain medication at day 28 (NCT00382265)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Tamsulosin22
Placebo24

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Stone Passage

Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day. (NCT00448123)
Timeframe: 1-7 days

Interventionparticipants (Number)
Placebo18
Tamsulosin21

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High Pain Score by Treatment Group

Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days. (NCT00448123)
Timeframe: 7 Days

Interventionunits on a scale (Mean)
Placebo1.69
Tamsulosin2.4

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Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge

(NCT00448123)
Timeframe: 1-7 days

InterventionPain tablets (Mean)
Placebo0.4
Tamsulosin0.6

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Change From Baseline in International Prostate Symptoms Score (IPSS)

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 65, 57)Week 8 (N=58, 67, 57)Week 12 (N=58, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-4.5-6.4-7.1-7.9-8.0
9 mg Solifenacin + 0.4 mg Tamsulosin-4.7-6.2-6.9-7.2-6.9
Placebo-3.8-5.3-6.8-6.9-6.6

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Change From Baseline in IPSS Storage Score

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=62, 67, 58)Week 4 (N=60, 66, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.6-2.6-2.8-3.3-3.4
9 mg Solifenacin + 0.4 mg Tamsulosin-2.1-2.5-3.1-3.1-3.0
Placebo-1.5-2.1-2.7-2.8-2.7

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Change From Baseline in IPSS Voiding Score

"The IPSS is a validated global questionnaire used to assess the degree of bother from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 65, 57)Week 8 (N=58, 67, 57)Week 12 (N=58, 64, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-2.9-3.8-4.3-4.7-4.6
9 mg Solifenacin + 0.4 mg Tamsulosin-2.6-3.6-3.8-4.1-3.9
Placebo-2.2-3.2-4.1-4.0-3.9

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Change From Baseline in Number of Incontinence Episodes Per 24 Hours

"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionincontinence episodes (Least Squares Mean)
Week 2 (N=13, 10, 13)Week 4 (N=13, 10, 13)Week 8 (N=12, 10, 12)Week 12 (N=12, 9, 12)End of Treatment (N=13, 10, 13)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.45-1.45-1.55-1.48-1.66
9 mg Solifenacin + 0.4 mg Tamsulosin-1.01-0.81-0.78-0.85-1.02
Placebo-0.81-1.00-1.86-1.99-1.54

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Change From Baseline in Number of Micturitions Per 24 Hours

"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionmicturitions (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.25-1.32-1.31-1.91-1.91
9 mg Solifenacin + 0.4 mg Tamsulosin-1.19-1.72-2.00-1.89-1.87
Placebo-0.44-1.03-1.33-1.07-0.95

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Change From Baseline in Number of Urgency Episodes Per 24 Hours

"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionurgency episodes (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-0.89-1.39-1.34-1.54-1.45
9 mg Solifenacin + 0.4 mg Tamsulosin-0.95-1.34-1.08-1.18-1.23
Placebo-0.59-1.18-1.45-1.47-1.41

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Change From Baseline in Patient Perception of Bladder Condition (PPBC)

"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 2 (N=61, 66, 58)Week 4 (N=60, 66, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 64, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin-0.3-0.5-0.8-1.0-0.9
9 mg Solifenacin + 0.4 mg Tamsulosin-0.5-0.9-1.1-1.1-1.1
Placebo-0.5-0.7-1.0-1.1-1.1

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Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score

"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=58, 66, 52)Week 8 (N=55, 63, 53)Week 12 (N=55, 61, 53)End of Treatment (N=60, 66, 57)
6 mg Solifenacin + 0.4 mg Tamsulosin-4.5-5.6-6.5-6.0
9 mg Solifenacin + 0.4 mg Tamsulosin-4.6-5.8-5.9-5.8
Placebo-3.9-5.5-5.5-5.2

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Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score

"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=52, 57, 48)Week 8 (N=51, 55, 47)Week 12 (N=51, 51, 47)End of Treatment (N=58, 60, 53)
6 mg Solifenacin + 0.4 mg Tamsulosin-11.0-19.4-23.9-21.1
9 mg Solifenacin + 0.4 mg Tamsulosin-17.0-20.7-23.9-22.4
Placebo-14.6-20.7-22.6-21.7

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Change From Baseline in Volume Voided Per Micturition

"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 2 (N=60, 67, 59)Week 4 (N=60, 65, 58)Week 8 (N=58, 67, 58)Week 12 (N=58, 65, 58)End of Treatment (N=60, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin31.4635.2733.7235.0236.26
9 mg Solifenacin + 0.4 mg Tamsulosin18.2530.3435.5331.1830.33
Placebo9.3610.4010.509.037.56

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Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests

Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. (NCT00507455)
Timeframe: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).

,,
Interventionparticipants (Number)
Any adverse eventMild adverse eventModerate adverse eventSevere adverse eventSerious adverse eventAE leading to study drug discontinuationDrug-related adverse eventsDeaths
6 mg Solifenacin + 0.4 mg Tamsulosin382113423240
9 mg Solifenacin + 0.4 mg Tamsulosin372012526260
Placebo29216213150

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Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score

"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=33, 36, 36)Week 8 (N=33, 32, 31)Week 12 (N=35, 33, 28)End of Treatment (N=39, 39, 38)
6 mg Solifenacin + 0.4 mg Tamsulosin-2.4-4.3-6.5-5.3
9 mg Solifenacin + 0.4 mg Tamsulosin-5.1-6.7-8.4-7.3
Placebo-2.7-3.6-4.8-4.7

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Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)

"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.63
6 mg Solifenacin + 0.4 mg Tamsulosin1.84
9 mg Solifenacin + 0.4 mg Tamsulosin3.86

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Change From Baseline in Post Void Residual Volume (PVR)

"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

,,
InterventionmL (Least Squares Mean)
Week 2 (N=61, 67, 58)Week 4 (N=60, 67, 59)Week 8 (N=58, 66, 58)Week 12 (N=57, 63, 57)End of Treatment (N=62, 67, 59)
6 mg Solifenacin + 0.4 mg Tamsulosin16.7814.929.6426.8125.63
9 mg Solifenacin + 0.4 mg Tamsulosin8.979.656.6418.7219.07
Placebo-10.21-7.86-12.441.160.14

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Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score

"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares (LS) means were adjusted for pooled center and the Baseline value." (NCT00507455)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Least Squares Mean)
Week 4 (N=57, 66, 56)Week 8 (N=56, 65, 55)Week 12 (N=56, 63, 55)End of Treatment (N=60, 66, 57)
6 mg Solifenacin + 0.4 mg Tamsulosin-1.2-1.7-2.0-1.9
9 mg Solifenacin + 0.4 mg Tamsulosin-1.3-1.8-2.2-2.1
Placebo-1.2-1.7-2.1-2.0

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Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)

"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency.~LS means were adjusted for pooled center and Baseline value." (NCT00507455)
Timeframe: Baseline and Week 12

InterventionPercent voiding efficiency (Least Squares Mean)
Placebo-0.67
6 mg Solifenacin + 0.4 mg Tamsulosin-1.38
9 mg Solifenacin + 0.4 mg Tamsulosin-3.79

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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine. (NCT00507455)
Timeframe: Baseline and Week 12

InterventionmL/sec (Least Squares Mean)
Placebo0.17
6 mg Solifenacin + 0.4 mg Tamsulosin1.85
9 mg Solifenacin + 0.4 mg Tamsulosin2.35

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Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)

Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry. (NCT00507455)
Timeframe: Baseline and Week 12

InterventioncmH2O (Least Squares Mean)
Placebo-1.69
6 mg Solifenacin + 0.4 mg Tamsulosin-7.84
9 mg Solifenacin + 0.4 mg Tamsulosin-6.69

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Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline12 Week Change
Placebo17.3-4.2
Tadalafil17.1-5.8
Tamsulosin17.7-5.6

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Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary

A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported. (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionaverage number per week (Mean)
Baseline12 Week Change
Placebo0.8-0.3
Tadalafil1.10.7
Tamsulosin1.6-0.3

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Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary

Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported. (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionaverage number per week (Mean)
Baseline Waking Voids12 Week Change Waking VoidsBaseline Sleeping Voids12 Week Change Sleeping VoidsBaseline Total Voids12 Week Change Total Voids
Placebo48.2-0.310.3-1.358.6-1.6
Tadalafil46.9-2.19.8-2.356.7-4.4
Tamsulosin48.4-1.37.9-1.456.3-2.7

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Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore

The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation. (NCT00540124)
Timeframe: baseline, 4, 8, and 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline (n=50, n=50, n=49)4 Week Change (n=50, n=49, n=49)8 Week Change (n=47, n=50, n=48)12 Week Change (n=47, n=48, n=48)
Placebo6.7-0.8-0.9-1.6
Tadalafil6.7-1.4-1.6-2.2
Tamsulosin6.5-1.7-1.9-1.8

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Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. (NCT00540124)
Timeframe: baseline, 4 and 8 weeks

,,
Interventionunits on a scale (Least Squares Mean)
4 Week Change (n=50, n=49, n=49)8 Week Change (n=47, n=50, n=48)
Placebo-2.8-3.3
Tadalafil-4.0-4.8
Tamsulosin-4.0-4.8

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Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore

IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia). (NCT00540124)
Timeframe: baseline, 4, 8, and 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline (n=50, n=50, n=49)4 Week Change (n=50, n=49, n=49)8 Week Change (n=47, n=50, n=48)12 Week Change (n=47, n=48, n=48)
Placebo2.0-0.3-0.4-0.5
Tadalafil1.8-0.4-0.4-0.5
Tamsulosin1.7-0.3-0.4-0.5

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Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore

The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction. (NCT00540124)
Timeframe: baseline, 4, 8, and 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline (n=50, n=50, n=49)4 Week Change (n=50, n=49, n=49)8 Week Change (n=47, n=50, n=48)12 Week Change (n=47, n=48, n=48)
Placebo10.6-2.0-2.3-2.7
Tadalafil10.4-2.6-3.1-3.6
Tamsulosin11.2-2.4-3.1-3.9

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Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)

The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit. (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline12 Week Change
Placebo6.2-2.0
Tadalafil6.1-2.2
Tamsulosin6.2-1.7

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Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies

"Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)." (NCT00540124)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
WorseNo ChangeBetter
Placebo0543
Tadalafil0841
Tamsulosin4440

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Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies

"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)." (NCT00540124)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
WorseNo ChangeBetter
Placebo11037
Tadalafil1543
Tamsulosin3738

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Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)

Vcomp, defined as the volume of voided urine (measured in milliliters [mL]). (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionmilliliters (Mean)
Baseline12 Week Change
Placebo220.021.4
Tadalafil233.219.7
Tamsulosin236.623.9

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Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)

Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter). (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionmilliliters per second (Mean)
Baseline Qmax12 Week Change QmaxBaseline Qmean12 Week Change Qmean
Placebo10.52.85.72.0
Tadalafil11.42.46.11.5
Tamsulosin11.71.96.21.0

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Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary

A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination). (NCT00540124)
Timeframe: baseline, 12 weeks

,,
Interventionaverage number per week (Mean)
Baseline Terminal Micturation Dribble12 Week Change Terminal Micturation DribbleBaseline Post Micturation Dribble12 Week Change Post Micturation Dribble
Placebo68.7-11.714.3-0.8
Tadalafil69.81.617.8-4.8
Tamsulosin77.5-8.525.5-7.6

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Benign Prostate Hyperplasia Impact Index

"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Benign Prostatic Hyperplasia Impact Index asked the following:~Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)~Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)~Overall, how bothersome has any trouble with urination been during the past month? (0-3)~Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13." (NCT00701779)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Dutasteride3.28

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Economic Impact

Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin. (NCT00701779)
Timeframe: 13 months

InterventionUS dollars (Mean)
Dutasteride643.99

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Health Outcome Measures

Number of participants who are able to subsequently reduce or discontinue Tamsulosin usage after starting with combination therapy with Dutasteride and Tamsulosin while still maintaining the same degree of improvement in lower urinary tract symptoms (NCT00701779)
Timeframe: 13 months

InterventionParticipants (Count of Participants)
Dutasteride31

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International Prostate Symptom Score

"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.~Total range is from 0-35. The scores are evaluated as such:~0-7: Mild 8-19: Moderate 20-35: Severe" (NCT00701779)
Timeframe: 12 months

Interventionunits on a scale (Mean)
Dutasteride11.31

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Peak Flow Rate (QMax)

Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. (NCT00701779)
Timeframe: 12 months

Interventionml/sec (Mean)
Dutasteride20.43

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Post-void Residual Volume

Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. (NCT00701779)
Timeframe: 12 months

InterventionmL (Mean)
Dutasteride87.19

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Prostate Specific Antigen

Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. (NCT00701779)
Timeframe: 12 months

Interventionng/mL (Mean)
Dutasteride1.91

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Safety and Tolerability

To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related. (NCT00701779)
Timeframe: 13 months

Interventionadverse events (Number)
Dutasteride27

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Change From Baseline in Urine Volume at Week 14

Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14. (NCT00796614)
Timeframe: Baseline and Week 14

InterventionmL (Least Squares Mean)
Placebo-2.3
Tamsulosin - Low Dose Level-32.2
Tamsulosin - Medium Dose Level4.4
Tamsulosin - High Dose Level3.3

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Change From Baseline in Number of Times Patient Was Wet at Catheterisation

Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary. (NCT00796614)
Timeframe: Baseline and Week 14

InterventionTimes patient wet at catheterization (Least Squares Mean)
Placebo0.3
Tamsulosin - Low Dose Level-1.7
Tamsulosin - Medium Dose Level0.0
Tamsulosin - High Dose Level-0.4

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Change From Baseline in LPP at Week 14 (End of Treatment)

Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP. (NCT00796614)
Timeframe: Baseline and Week 14

Interventioncm H2O (Least Squares Mean)
Placebo-11.4
Tamsulosin - Low Dose Level-17.6
Tamsulosin - Medium Dose Level-4.6
Tamsulosin - High Dose Level-14.3

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Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.

"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.~Relevant findings or worsening of baseline conditions were reported as adverse events." (NCT00796614)
Timeframe: From first drug administration until 28 days after last study drug administration, upto 160 days

,,,
InterventionParticipants (Number)
Occurrence of treatment emergent adverse eventsPremature discontinuation of study drug due to AESinus tachycardia
Placebo1810
Tamsulosin - High Dose Level1501
Tamsulosin - Low Dose Level3920
Tamsulosin - Medium Dose Level2400

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Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.

The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed. (NCT00796614)
Timeframe: Week 14

InterventionPercentage of participants (Number)
Placebo35.3
Tamsulosin - Low Dose Level45.7
Tamsulosin - Medium Dose Level27.3
Tamsulosin - High Dose Level42.4

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Post Void Residual Volume at Week 14

Median change from baseline to Week 14 in post void residual (mL) by study treatment. (NCT00796614)
Timeframe: Baseline and Week 14.

InterventionmL (Median)
Placebo3
Tamsulosin - Low Dose Level-19
Tamsulosin - Medium Dose Level-1.5
Tamsulosin - High Dose Level0.00

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Percentage Change From Baseline in LPP at Week 14 (End of Treatment)

Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP. (NCT00796614)
Timeframe: Baseline and Week 14.

InterventionPercentage change (Least Squares Mean)
Placebo-19.9
Tamsulosin - Low Dose Level-27.4
Tamsulosin - Medium Dose Level-1.9
Tamsulosin - High Dose Level-23.9

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Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline

"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.~The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization" (NCT00796614)
Timeframe: Baseline and Week 14

,,,
InterventionParticipants (Number)
Left Kidney [N= 34; 34; 33; 40]Right Kidney [N= 33; 34; 34; 40]
Placebo3231
Tamsulosin - High Dose Level3738
Tamsulosin - Low Dose Level3133
Tamsulosin - Medium Dose Level3130

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Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline

"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).~Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14." (NCT00796614)
Timeframe: Baseline and Week 14

,,,
InterventionParticipants (Number)
Left Kidney (N= 34, 34, 33, 40)Right Kidney (N= 33, 34, 34, 40)
Placebo3333
Tamsulosin - High Dose Level3838
Tamsulosin - Low Dose Level3333
Tamsulosin - Medium Dose Level3232

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Time to Stone Passage

The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage. (NCT00831701)
Timeframe: 21 days

Interventiondays (Median)
Tamsulosin Treatment7
Placebo Treatment10

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Required Analgesics

Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day (NCT00831701)
Timeframe: Until stone expulsion or up to 21 days

Interventionpills per day (Median)
Tamsulosin Treatment3
Placebo Treatment7

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Number of Participants With Stone Expulsion

The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT). (NCT00831701)
Timeframe: 21 days

InterventionParticipants (Number)
Tamsulosin Treatment39
Placebo Treatment40

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Number of Participants Requiring Active Treatment

The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment. (NCT00831701)
Timeframe: 21 days

Interventionparticipants (Number)
Tamsulosin Treatment6
Placebo Treatment4

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Maximum Daily Pain Score

All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine). (NCT00831701)
Timeframe: Until stone expulsion or up to 21 days

InterventionUnits on a scale (Median)
Tamsulosin Treatment3
Placebo Treatment7

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Change From Baseline in Blood Pressure (Standing) at 12 Weeks

(NCT00861757)
Timeframe: baseline, 12 weeks

,,,
Interventionmm Hg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
0.2 mg Tamsulosin-0.9-1.0
2.5 mg Tadalafil-2.9-2.3
5.0 mg Tadalafil0.6-1.7
Placebo0.80.4

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Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks

Nanograms of PSA per milliliter (ng/mL) of blood. (NCT00861757)
Timeframe: baseline, 12 weeks

Interventionmicrogram/Liter (Mean)
Placebo-0.03
2.5 mg Tadalafil0.04
5.0 mg Tadalafil0.13
0.2 mg Tamsulosin-0.06

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Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks

(NCT00861757)
Timeframe: baseline, 12 weeks

Interventionbeats per minute (bpm) (Mean)
Placebo-0.3
2.5 mg Tadalafil0.7
5.0 mg Tadalafil0.6
0.2 mg Tamsulosin0.6

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Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks

"Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value." (NCT00861757)
Timeframe: baseline, 12 weeks

Interventionmilliliter per second (mL/sec) (Least Squares Mean)
Placebo2.1
2.5 mg Tadalafil1.6
5.0 mg Tadalafil1.3
0.2 mg Tamsulosin2.1

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Change From Baseline in Blood Pressure (Sitting) at 12 Weeks

(NCT00861757)
Timeframe: baseline, 12 weeks

,,,
Interventionmm Hg (Mean)
Systolic Blood PressureDiastolic Blood Pressure
0.2 mg Tamsulosin0.2-0.6
2.5 mg Tadalafil-2.3-2.5
5.0 mg Tadalafil-0.5-1.4
Placebo0.9-0.3

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Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])

IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. (NCT00861757)
Timeframe: baseline, 12 weeks

,,,
Interventionunits on a scale (Least Squares Mean)
Voiding (Obstructive) Score (N = 154,151,155,152)Storage (Irritative) Score (N = 154,151,155,152)
0.2 mg Tamsulosin-3.8-1.7
2.5 mg Tadalafil-3.3-1.5
5.0 mg Tadalafil-3.0-1.7
Placebo-1.9-1.1

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Clinician Global Impression of Improvement (CGI-I) at Week 12

The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). (NCT00861757)
Timeframe: 12 weeks

,,,
Interventionparticipants (Number)
Very Much WorseMuch WorseA Little WorseNo ChangeA Little BetterMuch BetterVery Much Better
0.2 mg Tamsulosin01319684712
2.5 mg Tadalafil23421673911
5.0 mg Tadalafil01329624810
Placebo0384460307

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Patient Global Impression of Improvement (PGI-I) at Week 12

The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). (NCT00861757)
Timeframe: 12 weeks

,,,
InterventionParticipants (Number)
Very Much WorseMuch WorseA Little WorseNo ChangeA Little BetterMuch BetterVery Much Better
0.2 mg Tamsulosin0142558539
2.5 mg Tadalafil1142662449
5.0 mg Tadalafil10523744010
Placebo23124554324

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Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks

The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. (NCT00861757)
Timeframe: baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.8
2.5 mg Tadalafil-1.1
5.0 mg Tadalafil-1.0
0.2 mg Tamsulosin-1.6

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Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks

"The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.~Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value." (NCT00861757)
Timeframe: baseline, 12 weeks

InterventionUnits on a scale (Least Squares Mean)
Placebo-3.0
2.5 mg Tadalafil-4.8
5 mg Tadalafil-4.7
0.2 mg Tamsulosin-5.5

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Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks

"Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value." (NCT00861757)
Timeframe: baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.5
2.5 mg Tadalafil-0.8
5.0 mg Tadalafil-0.8
0.2 mg Tamsulosin-1.1

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Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks

The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound. (NCT00861757)
Timeframe: baseline, 12 weeks

Interventionmilliliter (mL) (Mean)
Placebo-1.20
2.5 mg Tadalafil-0.09
5.0 mg Tadalafil-2.90
0.2 mg Tamsulosin-5.67

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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks

IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo2.1
Tadalafil 5 mg6.0
Tamsulosin 0.4 mg1.7

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Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks

BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 4 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.4
Tadalafil 5 mg-1.2
Tamsulosin 0.4 mg-1.3

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Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks

BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.9
Tadalafil 5 mg-1.7
Tamsulosin 0.4 mg-1.5

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Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks

The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-4.2
Tadalafil 5 mg-6.3
Tamsulosin 0.4 mg-5.7

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Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks

The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 4 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-3.3
Tadalafil 5 mg-5.5
Tamsulosin 0.4 mg-5.7

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Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks

V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionmilliliter (mL) (Median)
Placebo0.0
Tadalafil 5 mg11.0
Tamsulosin 0.4 mg16.0

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Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall

The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction. (NCT00970632)
Timeframe: 12 weeks

Interventionunits on a scale (Median)
Placebo28.9
Tadalafil 5 mg22.2
Tamsulosin 0.4 mg28.9

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Clinician Global Impression of Improvement (CGI-I) at 12 Weeks

"The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant's symptoms based on a 7-point scale. A score of 1=participant felt symptoms were very much better; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt no change in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were very much worse." (NCT00970632)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
Very much worseMuch worseA little worseNo changeA little betterMuch betterVery much better
Placebo1265157349
Tadalafil 5 mg02532585016
Tamsulosin 0.4 mg0174065386

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Patient Global Impression of Improvement (PGI-I) at 12 Weeks

"The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant's symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were very much better; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt no change in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were very much worse." (NCT00970632)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
Very much worseMuch worseA little worseNo changeA little betterMuch betterVery much better
Placebo22451533611
Tadalafil 5 mg01628525617
Tamsulosin 0.4 mg00836554810

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Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks

IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-1.6
Tadalafil 5 mg-2.2
Tamsulosin 0.4 mg-2.2

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Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks

IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-1.0
Tadalafil 5 mg-1.3
Tamsulosin 0.4 mg-1.1

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Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.

IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-2.6
Tadalafil 5 mg-4.1
Tamsulosin 0.4 mg-3.5

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Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks

Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionmilliliters per second (mL/sec) (Median)
Placebo0.10
Tadalafil 5 mg1.25
Tamsulosin 0.4 mg0.70

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Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week

The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 1 week

Interventionunits on a scale (Least Squares Mean)
Placebo-2.5
Tadalafil 5 mg-4.0
Tamsulosin 0.4 mg-4.0

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Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks

The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo-0.3
Tadalafil 5 mg-0.5
Tamsulosin 0.4 mg-0.5

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Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks

Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionmilliliters per second (mL/sec) (Median)
Placebo0.3
Tadalafil 5 mg1.6
Tamsulosin 0.4 mg1.6

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Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks

PVR was the amount of urine remaining in the bladder after void completion. (NCT00970632)
Timeframe: Baseline, 12 weeks

Interventionmilliliter (mL) (Median)
Placebo0.0
Tadalafil 5 mg-1.0
Tamsulosin 0.4 mg-5.5

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Maximum Concentration at Steady State (Cmaxss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionng/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg7.808.328.38
FDC 0.4 mg/9 mg8.008.468.16
TOCAS 0.4 mg7.387.697.97

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Change From Baseline to End of Treatment in EQ-5D Self-care Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to wash/ dressNo problem -> No DataSome problem -> No problemSome problem -> Some problemSome problem -> Unable to wash/ dressSome problem -> No dataUnable to wash/ dress -> No problemUnable to wash/ dress -> Some problemUnable to wash/ dress -> Unable to wash/ dressUnable to wash/ dress -> No dataNo data -> No problemNo data -> Some problemNo data -> Unable to wash/ dressNo data -> No data
FDC 0.4 mg/6 mg293301860010001000
FDC 0.4 mg/9 mg286404330000001000
Placebo295803830000001000
TOCAS 0.4 mg273801680000101000

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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No pain -> No painNo pain -> Moderate painNo pain -> Extreme painNo pain -> No dataModerate pain-> No painModerate pain-> Moderate painModerate pain-> Extreme painModerate pain-> No dataExtreme pain -> No painExtreme pain -> Moderate painExtreme pain -> Extreme painExtreme pain -> No dataNo data -> No painNo data -> Moderate painNo data -> Extreme painNo data -> No data
FDC 0.4 mg/6 mg153191161721012200000
FDC 0.4 mg/9 mg152240241701234200000
Placebo162142355732004100200
TOCAS 0.4 mg159141041722212202000

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Change From Baseline to End of Treatment in EQ-5D Mobility Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Confined to bedNo problem -> No dataSome problem -> No problemSome problem -> Some problemSome problem -> Confined to bedSome problem -> No dataConfined to bed -> No problemConfined to bed -> Some problemConfined to bed -> Confined to bedConfined to bed -> No dataNo data -> No problemNo data -> Some problemNo data -> Confined to bedNo data -> No data
FDC 0.4 mg/6 mg255100112350000000000
FDC 0.4 mg/9 mg233130319310100001000
Placebo240160319400000000000
TOCAS 0.4 mg230131121310000001000

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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> Moderately anxiousNot anxious -> Extremely anxiousNot anxious -> No dataModerately anxious -> Not anxiousModerately anxious -> Moderately anxiousModerately anxious -> Extremely anxiousModerately anxious -> No dataExtremely anxious -> Not anxiousExtremely anxious -> Moderately anxiousExtremely anxious -> Extremely anxiousExtremely anxious -> No dataNo data -> Not anxiousNo data -> Moderately anxiousNo data -> Extremely anxiousNo data -> No data
FDC 0.4 mg/6 mg233160127391011301000
FDC 0.4 mg/9 mg214180325341103200000
Placebo219160334421020100000
TOCAS 0.4 mg213110025432100201000

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AUCss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

,
Interventionng.h/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg657673652
FDC 0.4 mg/9 mg9701020988

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Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score

"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo8.3
TOCAS 0.4 mg8.8
FDC 0.4 mg/6 mg11.9
FDC 0.4 mg/9 mg10.0

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Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score

"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo7.5
TOCAS 0.4 mg9.3
FDC 0.4 mg/6 mg12.0
FDC 0.4 mg/9 mg11.5

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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score

Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Mean)
Placebo4.0
TOCAS 0.4 mg3.7
FDC 0.4 mg/6 mg5.5
FDC 0.4 mg/9 mg6.2

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Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours

An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionurgency episodes (Least Squares Mean)
Placebo-1.6
TOCAS 0.4 mg-2.5
FDC 0.4 mg/6 mg-2.6
FDC 0.4 mg 9 mg-2.8

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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)

Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL/s (Mean)
Placebo1.5
TOCAS 0.4 mg1.3
FDC 0.4 mg/6 mg1.9
FDC 0.4 mg/9 mg1.7

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Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionnocturia episodes (Least Squares Mean)
Placebo-0.3
TOCAS 0.4 mg-0.4
FDC 0.4 mg/6 mg-0.5
FDC 0.4 mg/9 mg-0.4

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Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours

The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionpads (Least Squares Mean)
Placebo-0.7
TOCAS 0.4 mg-0.8
FDC 0.4 mg/6 mg-1.2
FDC 0.4 mg/9 mg-1.2

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Tmaxss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionh (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg5.475.485.48
FDC 0.4 mg/9 mg5.475.485.48

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Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionh (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg5.065.105.09
FDC 0.4 mg/9 mg5.085.115.09
TOCAS 0.4 mg5.045.095.10

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Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
FDC 0.4 mg/6 mg209512446200
FDC 0.4 mg/9 mg2310510538910
Placebo775113861250
TOCAS 0.4 mg148599681330

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Patient Global Impression Scale at End of Treatment: General Health

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch Worse• Very Much Worse
FDC 0.4 mg/6 mg107287110800
FDC 0.4 mg/9 mg77594941010
Placebo543791521520
TOCAS 0.4 mg95877126930

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Number of Participants With Adverse Events (AEs)

Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug. (NCT01018511)
Timeframe: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)

,,,
Interventionparticipants (Number)
Total TEAEsMild TEAEsModerate TEAEsSevere TEAEsDrug-related TEAEsSAEsDeathsAEs Leading to DiscontinDrug-related AEs Leading to Discontin
FDC 0.4 mg/6 mg99682745751139
FDC 0.4 mg/9 mg100682756590108
Placebo8759253303053
TOCAS 0.4 mg74422932710195

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Minimum Concentration at Steady State (Cminss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
Interventionng/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg4.555.085.05
FDC 0.4 mg/9 mg4.755.194.94
TOCAS 0.4 mg4.194.634.84

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Change From Baseline to End of Treatment in Symptom Bother Score

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-11.8
TOCAS 0.4 mg-14.4
FDC 0.4 mg/6 mg-16.5
FDC 0.4 mg/9 mg-17.1

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Cminss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionng/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg24.525.224.4
FDC 0.4 mg/9 mg36.138.237.0

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Cmaxss of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
Interventionng/mL (Geometric Mean)
Week 4 [N= 281; 273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg29.430.029.1
FDC 0.4 mg/9 mg43.445.344.1

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Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms

The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse). (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
FDC 0.4 mg/6 mg221179748210
FDC 0.4 mg/9 mg201249237340
Placebo99511172910
TOCAS 0.4 mg151069854510

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CL/F of Solifenacin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,
InterventionL/h (Geometric Mean)
Week 4 [N= 281;273]Week 8 [N= 258; 248]Week 12 [N= 166; 167]
FDC 0.4 mg/6 mg6.886.726.94
FDC 0.4 mg/9 mg7.006.676.87

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Change From Baseline to End of Treatment in Individual IPSS Scores

"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionunits on a scale (Least Squares Mean)
Incomplete emptying of the bladderFrequencyIntermittencyUrgencyWeak streamHesitancyNocturia
FDC 0.4 mg/6 mg-1.0-1.3-1.0-1.4-1.3-0.8-0.8
FDC 0.4 mg/9 mg-1.0-1.4-0.7-1.6-1.3-0.7-0.6
Placebo-0.9-1.0-0.9-1.2-1.1-0.5-0.5
TOCAS 0.4 mg-0.9-1.2-0.8-1.3-1.3-0.7-0.7

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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01018511)
Timeframe: Baseline and Week 12

,,,
Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to perform usual activitiesNo problem -> No dataSome problem -> No problemSome problem -> Some problemSome problem -> Unable to perform usual activitiesSome problem -> No dataUnable to perform usual activities -> No problemUnable to perform usual activities -> Some problemUnable to perform usual activities -> same statusUnable to perform usual activities -> No dataNo data -> No problemNo data -> Some problemNo data -> Unable to perform usual activitiesNo data -> No data
FDC 0.4 mg/6 mg248140126220020000000
FDC 0.4 mg/9 mg235180327170100000000
Placebo254180321220000000000
TOCAS 0.4 mg228131122280011102000

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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionmicturitions (Least Squares Mean)
Placebo-1.1
TOCAS 0.4 mg-1.7
FDC 0.4 mg/6 mg-2.3
FDC 0.4 mg/9 mg-1.9

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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionincontinence episodes (Least Squares Mean)
Placebo0.1
TOCAS 0.4 mg-0.2
FDC 0.4 mg/6 mg0.0
FDC 0.4 mg/9 mg0.1

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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo-5.9
TOCAS 0.4 mg-1.8
FDC 0.4 mg/6 mg12.7
FDC 0.4 mg/9 mg12.9

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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL/s (Mean)
Placebo3.3
TOCAS 0.4 mg3.2
FDC 0.4 mg/6 mg3.8
FDC 0.4 mg/9 mg3.5

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Change From Baseline to End of Treatment in IPSS Voiding Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-3.0
TOCAS 0.4 mg-3.3
FDC 0.4 mg/6 mg-3.7
FDC 0.4 mg/9 mg-3.2

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Change From Baseline to End of Treatment in IPSS Storage Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-2.4
TOCAS 0.4 mg-2.9
FDC 0.4 mg/6 mg-3.5
FDC 0.4 mg/9 mg-3.3

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Change From Baseline to End of Treatment in IPSS QoL Score

The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.9
TOCAS 0.4 mg-1.0
FDC 0.4 mg/6 mg-1.3
FDC 0.4 mg/9 mg-1.3

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Change From Baseline to End of Treatment in HRQoL Subscale: Total Score

"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo7.4
TOCAS 0.4 mg8.8
FDC 0.4 mg/6 mg11.4
FDC 0.4 mg/9 mg10.7

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Change From Baseline to End of Treatment in HRQoL Subscale: Social Score

"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo3.8
TOCAS 0.4 mg4.5
FDC 0.4 mg/6 mg6.2
FDC 0.4 mg/9 mg5.8

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Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

Interventionurgency incontinence episodes (Least Squares Mean)
Placebo-1.0
TOCAS 0.4 mg-1.4
FDC 0.4 mg/6 mg-1.3
FDC 0.4 mg/9 mg-1.1

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Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Least Squares Mean)
Placebo11.1
TOCAS 0.4 mg15.5
FDC 0.4 mg/6 mg38.6
FDC 0.4 mg/9 mg38.7

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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume

PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01018511)
Timeframe: Baseline and Week 12

InterventionmL (Mean)
Placebo-6.1
TOCAS 0.4 mg-5.0
FDC 0.4 mg/6 mg3.8
FDC 0.4 mg/9 mg12.3

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Change From Baseline to End of Treatment in Total International Prostate Symptom Score

"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-5.4
TOCAS 0.4 mg-6.2
FDC 0.4 mg/6 mg-7.0
FDC 0.4 mg/9 mg-6.5

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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])

"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01018511)
Timeframe: Baseline and Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-4.4
TOCAS 0.4 mg-6.7
FDC 0.4 mg/6 mg-8.1
FDC 0.4 mg/9 mg-7.6

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Percentage of Participants Who Were OAB-q Responders at End of Treatment

A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10. (NCT01018511)
Timeframe: Week 12 (end of treatment)

Interventionpercentage of participants (Number)
Placebo40.8
TOCAS 0.4 mg42.9
FDC 0.4 mg/6 mg45.5
FDC 0.4 mg/9 mg47.5

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Apparent Clearance (CL/F) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12

,,
InterventionL/h (Geometric Mean)
Week 4 [N=263; 281; 274]Week 8 [N=255; 259; 248]Week 12 [N=163; 167; 166]
FDC 0.4 mg/6 mg2.612.412.40
FDC 0.4 mg/9 mg2.532.362.46
TOCAS 0.4 mg2.782.622.52

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Area Under the Curve at Steady State (AUCss) of Tamsulosin

(NCT01018511)
Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

,,
Interventionng.h/mL (Geometric Mean)
Week 4 [N= 263; 281; 274]Week 8 [N= 255; 259; 248]Week 12 [N= 163; 167; 166]
FDC 0.4 mg/6 mg153166167
FDC 0.4 mg/9 mg158169162
TOCAS 0.4 mg144153159

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Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score

The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-1.9

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Change From Baseline to End of Treatment in IPSS Storage Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-4.3

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Change From Baseline to End of Treatment in IPSS Voiding Score

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-4.7

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Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

Qmax during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml/s (Mean)
Total Group4.54

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Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group16.6

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Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score

Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state). (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group6.4

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Change From Baseline to End of Treatment in Individual IPSS Scores

"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Incomplete emptying of the bladderFrequencyIntermittencyUrgencyWeak streamHesitancyNocturia
Total Group-1.3-1.7-1.0-1.8-1.6-0.8-0.9

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Change From Baseline to End of Treatment in EQ-5D Usual Activities Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> unable to perform usual activitiesNo problem -> no dataSome problem -> no problemSome problem -> some problemSome problem -> unable to perform usual activitiesSome problem -> no dataUnable to perform usual activities -> no problemUnable to perform usual activities -> some problemUnable to perform usual activities -> same statusUnable to perform usual activities -> no dataNo data -> no problemNo data -> some problemNo data -> unable to perform usual activitiesNo data -> no data
Total Group805541080600012001000

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Change From Baseline to End of Treatment in EQ-5D Self-care Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> Unable to wash/dressNo problem -> No dataSome problem -> no problemSome problem -> some problemSome problem -> unable to wash/dressSome problem -> no dataUnable to wash/dress -> no problemUnable to wash/dress -> some problemUnable to wash/dress -> unable to wash/dressUnable to wash/dress -> no dataNo data -> no problemNo data -> some problemNo data -> unable to wash/dressNo data -> no data
Total Group934271018190020003000

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Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No pain -> no painNo pain -> moderate painNo pain -> extreme painNo pain -> no dataModerate pain -> no painModerate pain -> moderate painModerate pain -> extreme painModerate pain -> no dataExtreme pain -> no painExtreme pain -> moderate painExtreme pain -> extreme painExtreme pain -> no dataNo data -> no painNo data -> moderate painNo data -> extreme painNo data -> no data
Total Group499712020220050107602000

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Change From Baseline to End of Treatment in EQ-5D Mobility Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
No problem -> No problemNo problem -> Some problemNo problem -> confined to bedNo problem -> no dataSome problem -> No problemSome problem -> Some problemSome problem -> confined to bedSome problem -> No dataConfined to bed -> no problemConfined to bed -> some problemConfined to bed -> confined to bedConfined to bed -> no dataNo data -> no problemNo data -> some problemNo data -> confined to bedNo data -> no data
Total Group7755810671020000001000

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Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score

"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionparticipants (Number)
Not anxious -> Not anxiousNot anxious -> moderately anxiousNot anxious -> extremely anxiousNot anxious -> no dataModerately anxious -> not anxiousModerately anxious -> moderately anxiousModerately anxious -> extremely anxiousModerately anxious -> no dataExtremely anxious -> not anxiousExtremely anxious -> moderately anxiousExtremely anxious -> extremely anxiousExtremely anxious -> no dataNo data -> not anxiousNo data -> moderately anxiousNo data -> extremely anxiousNo data -> no data
Total Group73737101031093044501000

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Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])

"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-10.1

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Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)

"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)." (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-9.0

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Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionincontinence episodes (Mean)
Total Group-1.4

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Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionmicturitions (Mean)
Total Group-2.5

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Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition

A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group39.0

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Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours

The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionpads (Mean)
Total Group-0.9

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Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours

An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionurgency episodes (Mean)
Total Group-3.1

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Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionurgency incontinence episodes (Mean)
Total Group-1.5

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Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionnocturia episodes (Mean)
Total Group-0.7

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Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume

PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml (Mean)
Total Group10.7

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Change From Baseline to End of Treatment in Average Flow Rate (Qmean)

Qmean during a micturition (urination) was recorded using uroflowmetry. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionml/s (Mean)
Total Group2.05

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Change From Baseline to End of Treatment in Symptom Bother Score

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement. (NCT01021332)
Timeframe: Baseline and up to 52 weeks of FDC treatment

Interventionunits on a scale (Mean)
Total Group-20.6

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Number of Participants With Adverse Events (AEs)

Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057). (NCT01021332)
Timeframe: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)

Interventionparticipants (Number)
Participants With Treatment-Emergent Adverse EventDrug-related AEsDrug-related SAEsAny TEAE causing discontinuation of study drug.
Total Group4992551269

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Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG

Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction. (NCT01028014)
Timeframe: 2 weeks

Interventionmicrovolts (Median)
Pseudoephedrine 120mg ER Daily-18
Solifenacin 5mg Daily10
Tamsulosin 0.4mg Daily11
Imipramine 25mg Daily-15
Cyclobenzaprine 10mg Daily12
Lactose Capsules, One Daily36

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Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry

Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual. (NCT01028014)
Timeframe: 2 weeks

Interventionmilliliters per second (Median)
Pseudoephedrine 120mg ER Daily-7.3
Solifenacin 5mg Daily5.0
Tamsulosin 0.4mg Daily-5.6
Imipramine 25mg Daily-6.6
Cyclobenzaprine 10mg Daily10.3
Lactose Capsules, One Daily10.4

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Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.

Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm. (NCT01028014)
Timeframe: 2 weeks

InterventionMilliamps (Median)
Pseudoephedrine 120mg ER Daily0.06
Solifenacin 5mg Daily0.06
Tamsulosin 0.4mg Daily-0.8
Imipramine 25mg Daily-0.12
Cyclobenzaprine 10mg Daily0.0
Lactose Capsules, One Daily0.03

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax (NCT01149733)
Timeframe: Blood samples drawn over 60 hour period

Interventionng/mL (Mean)
Tamsulosin8.8694
Flomax®9.0150

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf (NCT01149733)
Timeframe: Blood samples drawn over 60 hour period

Interventionng*h/mL (Mean)
Tamsulosin143.2749
Flomax®157.9455

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t (NCT01149733)
Timeframe: Blood samples drawn over 60 hour period

Interventionng*h/mL (Mean)
Tamsulosin137.0248
Flomax®148.9023

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Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone0.1
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.1

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Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone0.0
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.2

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Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionvoids per day (Mean)
Behavioral Treatment Alone4.6
Drug Therapy (Tolterodine + Tamsulosin)4.6
Combined Behavioral + Drug Therapy5.2

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Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionEpisodes per week (Mean)
Behavioral Treatment Alone1.3
Drug Therapy (Tolterodine + Tamsulosin)1.5
Combined Behavioral + Drug Therapy0.0

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Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionepisodes per week (Mean)
Behavioral Treatment Alone3.4
Drug Therapy (Tolterodine + Tamsulosin)3.1
Combined Behavioral + Drug Therapy5.2

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Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionvoids per day (Mean)
Behavioral Treatment Alone2.7
Drug Therapy (Tolterodine + Tamsulosin)1.5
Combined Behavioral + Drug Therapy3.3

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Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination. (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionVoids per day (Mean)
Behavioral Treatment Alone0.7
Drug Therapy (Tolterodine + Tamsulosin)1.4
Combined Behavioral + Drug Therapy0.2

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Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination (NCT01175382)
Timeframe: Baseline to 12 weeks

InterventionVoids per day (Mean)
Behavioral Treatment Alone3.3
Drug Therapy (Tolterodine + Tamsulosin)2.9
Combined Behavioral + Drug Therapy3.5

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Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)

Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone6.7
Drug Therapy (Tolterodine + Tamsulosin)6.7
Combined Behavioral + Drug Therapy8.8

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Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)

Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone4.0
Drug Therapy (Tolterodine + Tamsulosin)4.4
Combined Behavioral + Drug Therapy7.9

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Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)

Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone2.7
Drug Therapy (Tolterodine + Tamsulosin)2.2
Combined Behavioral + Drug Therapy0.8

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Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia (NCT01175382)
Timeframe: Change from 6 weeks to 12 weeks

InterventionVoids per night (Mean)
Behavioral Treatment Alone0.1
Drug Therapy (Tolterodine + Tamsulosin)0.3
Combined Behavioral + Drug Therapy0.1

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Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionvoids per night (Mean)
Behavioral Treatment Alone0.7
Drug Therapy (Tolterodine + Tamsulosin)0.4
Combined Behavioral + Drug Therapy0.8

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Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)

Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionvoids per night (Mean)
Behavioral Treatment Alone0.8
Drug Therapy (Tolterodine + Tamsulosin)0.7
Combined Behavioral + Drug Therapy0.9

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Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)

Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: Change from 6 week to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone17.3
Drug Therapy (Tolterodine + Tamsulosin)10.8
Combined Behavioral + Drug Therapy4.6

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Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)

Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 12 weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone37.3
Drug Therapy (Tolterodine + Tamsulosin)31.0
Combined Behavioral + Drug Therapy42.1

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Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)

Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone19.9
Drug Therapy (Tolterodine + Tamsulosin)20.2
Combined Behavioral + Drug Therapy37.5

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Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)

Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort. (NCT01175382)
Timeframe: From Baseline to 6 Weeks

Interventionunits on a scale (Mean)
Behavioral Treatment Alone-0.1
Drug Therapy (Tolterodine + Tamsulosin)0.1
Combined Behavioral + Drug Therapy0.2

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Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach

The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT01294592)
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

,
InterventionScores on a scale (Least Squares Mean)
Month 1, n=357, 366Month 3, n=359, 368Month 6, n=359, 368Month 9, n=359, 368Month 12, n=359, 368Month 15, n=359, 368Month 18, n=359, 368Month 21, n=359, 368Month 24, n=359, 368
Dutasteride Plus Tamsulosin-1.3-1.8-1.9-2.1-2.1-2.2-2.2-2.4-2.4
Watchful Waiting All: Escalated Yes and No-0.4-1.0-1.3-1.5-1.5-1.5-1.4-1.6-1.6

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Exposure to Study Drug

Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group. (NCT01294592)
Timeframe: Up to 2 years

Interventiondays (Mean)
Dutasteride Plus Tamsulosin639.8
Watchful Waiting Escalated=Yes566.3

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Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization

A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs. (NCT01294592)
Timeframe: Up to 2 years

,,
InterventionParticipants (Number)
Any AEAny SAE
Dutasteride Plus Tamsulosin19038
Watchful Waiting All: Escalated Yes and No11925
Watchful Waiting Escalated=Yes9519

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Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach

Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). (NCT01294592)
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

,
InterventionParticipants (Number)
Month 1, >=2 points, n=358, 367Month 1, >=3 points, n=358, 367Month 1, >=25 percent, n=358, 367Month 3, >=2 points, n=359, 368Month 3, >=3 points, n=359, 368Month 3, >=25 percent, n= 359, 368Month 6, >=2 points, n=359, 368Month 6, >=3 points, n=359, 368Month 6, >=25 percent, n=359, 368Month 9, >=2 points, n=359, 368Month 9, >=3 points, n=359, 368Month 9, >=25 percent, n=359, 368Month 12, >=2 points, n=359, 368Month 12, >=3 points, n=359, 368Month 12, >=25 percent, n= 359, 368Month 15, >=2 points, n=359, 368Month 15, >=3 points, n=359, 368Month 15, >=25 percent, n=359, 368Month 18, >=2 points, n=359, 368Month 18, >=3 points, n=359, 368Month 18, >=25 percent, 359, 368Month 21, >=2 points, n=359, 368Month 21, >=3 points, n=359, 368Month 21, >=25 percent, n= 359, 368Month 24, >=2 points, n=359, 368Month 24, >=3points, n=359, 368Month 24, >=25 percent, n= 359, 368
Dutasteride Plus Tamsulosin225182161277233218277245229286257247291261249289259245288262245292267253295277261
Watchful Waiting All: Escalated Yes and No1499076221172150250208189276222207273229214275243231268229212274237224279234221

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Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH

"CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group." (NCT01294592)
Timeframe: Up to Month 24

,
InterventionParticipants (Number)
Participants with CP of BPH, n=369, 373BPH symptom progression, n=65, 108BPH-related AUR, n=65, 108BPH-related incontinence, n=65, 108Recurrent BPH-related UTI, n=65, 108BPH-related renal insufficiency, n=65, 108Tied for first component, n=65, 108Multiple components (2 components), n=65, 108Multiple components (3 components), n=65, 108Multiple components (>=4 components), n=65, 108
Dutasteride Plus Tamsulosin655924000400
Watchful Waiting All: Escalated Yes and No1089743400911

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Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach

"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study." (NCT01294592)
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

,
InterventionParticipants (Number)
Baseline, Any Satisfaction, n=315, 328Baseline, Neutral/Any Dissatisfaction, n=315, 328Month 1, Any Satisfaction, n=358, 349Month 1, Neutral/Any Dissatisfaction, n=358, 349Month 3, Any Satisfaction, n= 359, 359Month 3, Neutral/Any Dissatisfaction, n=359, 359Month 6, Any Satisfaction, n=359, 361Month 6, Neutral /Any Dissatisfaction, n=359, 361Month 9, Any Satisfaction, n=359, 361Month 9, Neutral/Any Dissatisfaction, n= 359, 361Month 12, Any Satisfaction, n=359, 363Month 12, Neutral/Any Dissatisfaction, n=359, 363Month 15, Any Satisfaction, n=359, 364Month 15, Neutral/Any Dissatisfaction, n=359, 364Month 18, Any Satisfaction, n=359, 364Month 18, Neutral/Any Dissatisfaction, n=359, 364Month 21, Any Satisfaction, n=359, 364Month 21, Neutral/Any Dissatisfaction, n=359, 364Month 24, Any Satisfaction, n=359, 364Month 24, Neutral/Any Dissatisfaction, n=359, 364
Dutasteride Plus Tamsulosin119196272863005930158304553114831148305543104931247
Watchful Waiting All: Escalated Yes and No1222062091402659428576293683055829965298663006431252

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Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach

"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study." (NCT01294592)
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

,
InterventionParticipants (Number)
Baseline, Yes, n=315, 328Baseline, No or Not Sure, n=315, 328Month 1, Yes, n=358, 347Month 1, No or Not Sure, n=358, 347Month 3, Yes, n=359, 357Month 3, No or Not Sure, n=359, 357Month 6, Yes, n=359, 360Month 6, No or Not Sure, n=359, 360Month 9, Yes, n=359, 361Month 9, No or Not Sure, n=359, 361Month 12, Yes, n=359, 363Month 12, No or Not Sure, n=359, 363Month 15, Yes, n=359, 364Month 15, No or Not Sure, n=359, 364Month 18, Yes, n=359, 364Month 18, No or Not Sure, n=359, 364Month 21, Yes, n=359, 364Month 21, No or Not Sure, n=359, 364Month 24, Yes, n=359, 364Month 24, No or Not Sure, n=359, 364
Dutasteride Plus Tamsulosin109206224134232127232127238121240119246113235124249110243116
Watchful Waiting All: Escalated Yes and No103225166181207150227133231130229134239125236128234130236128

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Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach

"The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study." (NCT01294592)
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

,
InterventionScores on a scale (Least Squares Mean)
Month 1, n=358, 367Month 3, n=359, 368Month 6, n=359, 368Month 9, n=359, 368Month 12, n=359, 368Month 15, n=359, 368Month 18, n=359, 368Month 21, n=359, 368Month 24, n=359, 368
Dutasteride Plus Tamsulosin-3.2-4.5-4.6-5.1-5.2-5.2-5.1-5.5-5.4
Watchful Waiting All: Escalated Yes and No-0.9-2.4-3.2-3.6-3.6-3.6-3.3-3.6-3.6

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Number of Events of Clinical Progression (CP) of BPH

The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing. (NCT01294592)
Timeframe: Up to 2 years

,
InterventionEvents (Number)
Year 1, n=369, 373Year 2, n=276, 251
Dutasteride Plus Tamsulosin4817
Watchful Waiting All: Escalated Yes and No9414

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Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.

The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-2.00-5.30-7.33

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Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionml/s (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-3.20-3.90-4.70

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Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg1.290.290.00

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Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg0.000.300

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Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionml (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-6.90-10.00-3.60

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Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-22.40-22.20-29.8

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Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)

The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Month 3

Interventionratio (Mean)
Baseline Characteristics-19.61

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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to week 12 (3 months)

Interventionpg/ml (Mean)
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg-10.9

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Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Interventionunits on a scale (Mean)
Change at Month 1Change at Month 2Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg34.6038.30-9.00

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Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.

Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores

Interventionratio (Mean)
Change at Month 1Change at Month 2
Baseline Characteristics-21.85-20.56

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Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8

Interventionpg/ml (Mean)
Change at Month 1Change at Month 2
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg11.1715.64

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Change in Total Score of OABSS

Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) (NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionunits on a scale (Mean)
Solifenacin-3.1
Solifenacin Plus Tamsulosin-3.5

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Change of PVR

Change from baseline in Post-Void Residual (PVR) volume (NCT01533597)
Timeframe: at week 24 relative to baseline

InterventionmL (Mean)
Solifenacin13.2
Solifenacin Plus Tamsulosin10.8

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Numeric Change of Urgency Episodes Per 24 Hours

(NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionepisodes (Mean)
Solifenacin-2.4
Solifenacin Plus Tamsulosin-2.1

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Change of Qmax

maximal urinary flow rate (Qmax) assessed by uroflowmetry (NCT01533597)
Timeframe: at week 24 relative to baseline

InterventionmL/sec (Mean)
Solifenacin1.1
Solifenacin Plus Tamsulosin2.1

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Change in Mean Number of Micturition Episodes Per 24 Hours

(NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionepisodes (Mean)
Solifenacin-1.9
Solifenacin Plus Tamsulosin-2.2

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Change in Score of IPSS

Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. (NCT01533597)
Timeframe: at week 24 relative to baseline

Interventionunits on a scale (Mean)
Solifenacin-7.7
Solifenacin Plus Tamsulosin-8.3

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Number of Participants Who Discontinued Treatment Due to an Adverse Event

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT01534351)
Timeframe: Up to 52 weeks

InterventionParticipants (Number)
Finasteride0

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Number of Participants Who Experienced an Adverse Event

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. (NCT01534351)
Timeframe: Up to 54 weeks

InterventionParticipants (Number)
Finasteride0

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American Urologic Association Symptom Score (AUASS)

AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome. (NCT01589263)
Timeframe: 3 months

Interventionscore on a scale (Mean)
ARM 1: onaBoNT-A + Placebo18.66
ARM 2: Saline + Tamsulosin14.16

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Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline

Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized. (NCT01673490)
Timeframe: Screening, Month 1, Month 3 and Month 6

InterventionParticipants (Number)
ALT, n=48AST, n=49Creatinine, n=51Glucose, n=47Potassium, n=52Protein, n=56Sodium, n=53Urea, n=54
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg96981407

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Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6

The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score. (NCT01673490)
Timeframe: Baseline and Month 6

InterventionScores on a scale (Mean)
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-8.3

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Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points

The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score. (NCT01673490)
Timeframe: Baseline, Month 3 and Month 6

InterventionMililiter/seconds (Mean)
Month 3, n=54Month 6, n=52
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg2.772.01

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Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points

Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value. (NCT01673490)
Timeframe: Baseline, Month 3 and Month 6

InterventionMicrogram per liter (ug/L) (Mean)
Month 3, n=54Month 6, n=52
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg-1.499-1.824

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Free to Total PSA Ratio at the Indicated Time Points

Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented. (NCT01673490)
Timeframe: Baseline, Month 6

InterventionRatio (Mean)
Baseline, n=50Month 6, n=52
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg28.20724.887

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Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points

A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5). (NCT01673490)
Timeframe: Screening, Month 1, Month 3 and Month 6

InterventionParticipants (Number)
Screening, n=59Month 1, n=56Month 3, n=53Month 6, n=52
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg49475044

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Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function. (NCT01673490)
Timeframe: From start of study medication until follow-up (up to 7 months)

InterventionParticipants (Number)
Any AEAny SAEAny treatment-related AE
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg211

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Number Participants With a Negative or Positive Response at the Indicated Time Points

Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized. (NCT01673490)
Timeframe: Screening, Month 3 and Month 6

InterventionParticipants (Number)
Erythrocytes, SC, POS, n=59Erythrocytes, SC, NEG, n=59Erythrocytes, 3M, POS, n=54Erythrocytes, 3M, NEG, n=54Erythrocytes, 6M, POS, n=52Erythrocytes, 6M, NEG, n=52Erythrocytes, FV, POS, n=54Erythrocytes, FV, NEG, n=54Glucose, SC, POS, n=59Glucose, SC, NEG, n=59Glucose, 3M, POS, n=54Glucose, 3M, NEG, n=54Glucose, 6M, POS, n=52Glucose, 6M, NEG, n=52Glucose, FV, POS, n=54Glucose, FV, NEG, n=54Ketones, SC, POS, n=59Ketones, SC, NEG, n=59Ketones, 3M, POS, n=54Ketones, 3M, NEG, n=54Ketones, 6M, POS, n=52Ketones, 6M, NEG, n=52Ketones, FV, POS, n=54Ketones, FV, NEG, n=54Leukocytes, SC, POS, n=59Leukocytes, SC, NEG, n=59Leukocytes, 3M, POS, n=54Leukocytes, 3M, NEG, n=54Leukocytes, 6M, POS, n=52Leukocytes, 6M, NEG, n=52Leukocytes, FV, POS, n=54Leukocytes, FV, NEG, n=54Protein, SC, POS, n=59Protein, SC, NEG, n=59Protein, 3M, POS, n=54Protein, 3M, NEG, n=54Protein, 6M, POS, n=52Protein, 6M, NEG, N=52Protein, FV, POS, n=54Protein, FV, NEG, n=54
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg455648646747356153052054059252151153356054646648950648745846

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Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline

Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized. (NCT01673490)
Timeframe: Screening, Month 3 and Month 6

InterventionParticipants (Number)
Basophils/Leukocytes, n=54Eosinophils/Leukocytes, n=46Ery Mean Corpuscular HGB Concentration, n=44Ery Mean Corpuscular Hemoglobin, n=36Ery Mean Corpuscular Volume, n=42Erythrocytes, n=49Erythrocytes Distribution Width, n=4Hematocrit, n=48Hemoglobin, n=49Leukocytes, n=47Lymphocytes/Leukocytes, n=53Monocytes/Leukocytes, n=52Neutrophils/Leukocytes, n=41Platelets, n=53
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg052264337271151

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Percentage of Participants Who Took no More Than One Capsule Per Day

Percentage of participants who took no more than one capsule per day (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride93.7

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Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population

"Percentage of participants who have a correct self-selection response as defined by the Uses, Allergy alert, and Do Not Use sections of the Drug Facts Label." (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride73.9

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Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population

Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride20.9

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Percentage of Participants Who Appropriately Followed the Label Instructions

"Includes subjects who reported:~No improvement in urinary symptoms and stopped taking product,~Reported worsening of urinary symptoms and stopped taking the product,~Reported a new urinary symptom and stopped taking the product,~Reported no Stop Use condition and never took more than 1 capsule on any given day,~Reported a Stop Use condition and contacted a provider." (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride85.4

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Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase

"Includes participants who:~were less than 45 years of age at enrollment, and~spoke to a doctor during the actual use phase." (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride30.4

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"Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day"

"Use-day was defind as a calendar day for which data were available regarding use or non-use." (NCT01726270)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Tamsulosin Hydrochloride94.1

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Ureteral Stent Symptom Questionnaire Score

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 42-48 hours post-stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.982.92.642.11.83
Tamsulosin Plus Placebo 7-day Treatment2.952.662.352.042.07
Tamsulosin Plus Tolterodine ER 21-day Treatment2.832.712.781.791.75
Tamsulosin Plus Tolterodine ER 7-day Treatment2.912.892.692.922

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Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: 5-7 days post-stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.492.582.521.941.75
Tamsulosin Plus Placebo 7-day Treatment2.462.392.342.811.5
Tamsulosin Plus Tolterodine ER 21-day Treatment2.462.42.281.472.9
Tamsulosin Plus Tolterodine ER 7-day Treatment2.552.492.332.611.59

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Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment1.851.971.842.131.58
Tamsulosin Plus Placebo 7-day Treatment1.721.661.731.571.42
Tamsulosin Plus Tolterodine ER 21-day Treatment2.142.081.991.562.42
Tamsulosin Plus Tolterodine ER 7-day Treatment1.911.661.671.411.3

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Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion

The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized. (NCT01741454)
Timeframe: Up to 24 hours prior to stent insertion

,,,
Interventionscore on a scale (Mean)
Urinary indexPain scoreGeneral health scoreWorkSexual matters
Tamsulosin Plus Placebo 21-day Treatment2.022.492.152.051.77
Tamsulosin Plus Placebo 7-day Treatment1.761.951.871.651.60
Tamsulosin Plus Tolterodine ER 21-day Treatment1.931.882.071.181.57
Tamsulosin Plus Tolterodine ER 7-day Treatment1.842.132.041.761.41

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Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months

Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Least Squares Mean)
Month 1, n=210, 208Month 3, n= 197, 196Month 6, n= 191, 179Month 9, n=177, 161Month 12, n= 173, 164
Duodart-3.2-5.8-7.5-7.6-7.5
Placebo-0.3-0.5-0.7-0.5-0.6

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Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months

Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Least Squares Mean)
Month 1, n=209, 215Month 3, n= 202, 208Month 6, n= 193, 188Month 9, n=182, 169Month 12, n= 175, 168
Duodart-0.5-0.7-1.0-1.2-1.0
Placebo-0.3-0.5-0.6-0.5-0.5

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Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months

The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Least Squares Mean)
Week 2, n=232, 234Month1, n=222, 231Month 3, n=217, 224Month 6, n=206, 203Month 9, n=193, 185Month 12, n=187, 184
Duodart-3.1-3.4-4.1-4.6-4.5-5.2
Placebo-1.5-2.8-2.8-2.9-3.2-3.2

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Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months

Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline, Week 2, Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Least Squares Mean)
Week 2, n=225, 227Month1, n=216, 223Month 3, n=211, 217Month 6, n=201, 195Month 9, n=188, 179Month 12, n=182, 177
Duodart-3.4-3.4-3.8-3.6-2.9-4.6
Placebo-0.4-1.3-1.7-1.0-1.6-1.0

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Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months

The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Least Squares Mean)
Week 2, n=226, 227Month1, n=216, 223Month 3, n=211, 217Month 6, n=201, 195Month 9, n=188, 179Month 12, n=183, 177
Duodart-0.7-0.7-1.1-1.2-1.2-1.2
Placebo-0.3-0.7-0.9-0.6-0.7-0.6

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Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months

Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, 9 and 12

,
InterventionScores on a scale (Mean)
Month 1, n=200, 197Month 3, n= 189, 182Month 6, n= 185, 168Month 9, n=173, 153Month 12, n= 169, 152
Duodart-0.8-0.5-1.5-1.2-0.6
Placebo0.10.40.2-0.00.3

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Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent

Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 12

InterventionScores on a scale (Least Squares Mean)
Placebo-0.6
Duodart-8.3

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Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points

Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 12

,
InterventionScores on a scale (Least Squares Mean)
IPSS improvement of >=2, n=152, 142IPSS improvement of >=3, n=138,136
Duodart-8.4-8.0
Placebo-0.6-0.6

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Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months

"Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where + indicates improvement and -indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test" (NCT01777269)
Timeframe: Baseline and 12 months

,
InterventionParticipants (Number)
>= 25>= 20>= 10<= -25<= -20<= -10
Duodart138132061
Placebo03163324

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Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months

Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s) (NCT01777269)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Placebo-0.7
Duodart-8.7

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Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months

Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles) (NCT01777269)
Timeframe: Baseline and Month 1, 3, 6, and 9

,
InterventionScores on a scale (Least Squares Mean)
Month 1, n=193, 192Month 3, n= 184, 181Month 6, n=179, 164Month 9, n=166, 146
Duodart-4.6-6.9-9.9-9.6
Placebo-0.5-0.5-0.8-0.8

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Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12

PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). (NCT01937871)
Timeframe: Week 12

,,
InterventionParticipants (Count of Participants)
Very Much WorseMuch WorseA Little WorseNo ChangeA Little BetterMuch BetterVery Much Better
0.2 mg Tamsulosin0013793396
5 mg Tadalafil0225316411913
Placebo03587169735

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Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12

"IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions." (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.85
5 mg Tadalafil-0.98
0.2 mg Tamsulosin-1.00

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Change From Baseline in IIEF Intercourse Satisfaction at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.05
5 mg Tadalafil1.08
0.2 mg Tamsulosin0.41

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Change From Baseline in IIEF Orgasmic Function at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo0.28
5 mg Tadalafil1.31
0.2 mg Tamsulosin0.57

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Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo0.62
5 mg Tadalafil1.54
0.2 mg Tamsulosin0.71

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Change From Baseline in IIEF Sexual Desire at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo0.46
5 mg Tadalafil1.12
0.2 mg Tamsulosin0.28

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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12

IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo1.88
5 mg Tadalafil5.24
0.2 mg Tamsulosin2.64

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Change From Baseline in IPSS at Week 12

IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-4.08
5 mg Tadalafil-5.49
0.2 mg Tamsulosin-4.92

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Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12

IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.68
5 mg Tadalafil-2.01
0.2 mg Tamsulosin-1.90

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Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12

IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-2.42
5 mg Tadalafil-3.49
0.2 mg Tamsulosin-3.07

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Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2

The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 2

Interventionunits on a scale (Least Squares Mean)
Placebo-2.19
5 mg Tadalafil-3.40
0.2 mg Tamsulosin-3.20

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Change From Baseline in Postvoid Residual Volume (PVR) at Week 12

The amount of urine remaining in the bladder after void completion. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionmilliliters (mL) (Mean)
Placebo-6.3
5 mg Tadalafil-3.8
0.2 mg Tamsulosin-9.5

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Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-4.08
5 mg Tadalafil-5.49
0.2 mg Tamsulosin-4.92

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Change From Baseline in Uroflowmetry Measures at Week 12

"Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).~At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group." (NCT01937871)
Timeframe: Baseline, Week 12

InterventionMilliliters/seconds (mL/sec) (Mean)
Placebo1.5
5 mg Tadalafil1.9
0.2 mg Tamsulosin2.0

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Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12

"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10." (NCT01937871)
Timeframe: Baseline, Week 12

Intervention"percentage of yes responses" (Least Squares Mean)
Placebo10.90
5 mg Tadalafil23.87
0.2 mg Tamsulosin6.84

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Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12

"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10." (NCT01937871)
Timeframe: Baseline, Week 12

Intervention"percentage of yes responses" (Least Squares Mean)
Placebo15.96
5 mg Tadalafil36.62
0.2 mg Tamsulosin17.42

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Change From Baseline in IIEF EF at Week 4 and Week 8

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 4; Baseline, Week 8

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8
0.2 mg Tamsulosin1.432.19
5 mg Tadalafil4.504.77
Placebo1.231.51

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Change From Baseline in IIEF Subscores at Week 12

IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 12

,,
Interventionunits on a scale (Least Squares Mean)
IIEF Question 3IIEF Question 4
0.2 mg Tamsulosin0.390.50
5 mg Tadalafil0.870.87
Placebo0.280.30

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Change From Baseline in Total IPSS at Week 4 and Week 8

IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10. (NCT01937871)
Timeframe: Baseline, Week 4; Baseline, Week 8

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8
0.2 mg Tamsulosin-3.92-4.44
5 mg Tadalafil-4.10-4.85
Placebo-2.99-3.50

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Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8

"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10." (NCT01937871)
Timeframe: Baseline, Week 4; Baseline, Week 8

,,
Intervention"percentage of yes responses" (Least Squares Mean)
Week 4Week 8
0.2 mg Tamsulosin6.217.42
5 mg Tadalafil20.5323.22
Placebo5.4310.79

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Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8

"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10." (NCT01937871)
Timeframe: Baseline, Week 4; Baseline, Week 8

,,
Intervention"percentage of yes responses" (Least Squares Mean)
Week 4Week 8
0.2 mg Tamsulosin9.5714.98
5 mg Tadalafil23.3832.27
Placebo7.4114.08

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Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12

CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse). (NCT01937871)
Timeframe: Week 12

,,
InterventionParticipants (Count of Participants)
Very Much WorseMuch WorseA Little WorseNo ChangeA Little BetterMuch BetterVery Much Better
0.2 mg Tamsulosin00139854110
5 mg Tadalafil1056614012021
Placebo0212911309216

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Number of Participants With Digital Rectal Examination (DRE)

DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: 6, 12, 18 , 24 months and final assessment

,
InterventionParticipants (Count of Participants)
Month 6, n=287, 285Month 12, n=279, 272Month 18, n=267, 258Month 24, n=261, 252Final Assessment, n=296, 295
Dut 0.5 mg + Tam 0.2 mg911121315
Placebo + Tam 0.2mg111061010

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Number of Participants With Hospital Admissions

Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded. (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
Out-patientIn-patient
Dut 0.5 mg + Tam 0.2 mg03
Placebo + Tam 0.2mg56

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Number of Subjects With AUR

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
OverallYear 1 subsetYear 2 subset
Dut 0.5 mg + Tam 0.2 mg220
Placebo + Tam 0.2mg1385

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Percent Change in Prostate Volume From Baseline

Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage. (NCT02058368)
Timeframe: Baseline,12 and 24 months

,
InterventionCubic centimeters (cc) (Mean)
Month 12, n=287, 286Month 24, n=287, 286
Dut 0.5 mg + Tam 0.2 mg-22.8-24.8
Placebo + Tam 0.2mg0.23.6

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Number of Participants With IPSS Improvement From Baseline

Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value. (NCT02058368)
Timeframe: Baseline and 3, 6, 9,12,15,18,21 and 24 months

,
InterventionParticipants (Number)
Month 3,>= 3 units, n=299, 296Month 3,>= 2 units, n=299,296Month 3,>= 25percent, n=299, 296Month 6,>= 3 units, n=300, 298Month 6,>= 2 units, n=300, 298Month 6,>= 25percent, n=300, 298Month 9,>= 3 units, n=300, 298Month 9,>= 2 units, n=300, 298Month 9,>= 25percent, n=300, 298Month 12,>= 3 units, n=300, 298Month 12,>= 2 units, n=300, 298Month 12,>= 25percent, n=300, 298Month 15,>= 3 units, n=300, 298Month 15,>= 2 units, n=300, 298Month 15,>= 25percent, n=300, 298Month 18,>= 3 units, n=300, 298Month 18,>= 2 units, n=300, 298Month 18,>= 25percent, n=300, 298Month 21,>= 3 units, n=300, 298Month 21,>= 2 units, n=300, 298Month 21,>= 25percent, n=300, 298Month 24,>= 3 units, n=300, 298Month 24,>= 2 units, n=300, 298Month 24,>= 25percent, n=300, 298
Dut 0.5 mg + Tam 0.2 mg157176123156176133177193150171191154186203160171187148178194161184197169
Placebo + Tam 0.2mg160190134156179131157185128154179131171186133156173136169186141156175137

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Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)

An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
Any Non-serious AEAny SAE
Dut 0.5 mg + Tam 0.2 mg20849
Placebo + Tam 0.2mg20352

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Number of Participants With Qmax Improvement From Baseline by LOCF Approach.

Qmax change from Baseline was presented using six improvement levels: >0 milliliter per second (mL/sec) and >=1 mL/sec through >=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: >0%, >=10%, >=20%, >=30%, >=40%, and >=50%. Here, Qmax improvement of >= 3 mL/sec and Qmax percentage of >= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. (NCT02058368)
Timeframe: Baseline 6, 12, 18 and 24 Months

,
InterventionParticipants (Count of Participants)
Month 6, >= 3 mL/sec, n=270, 274Month 6, >= 3 %, n=270, 274Month 12, >= 3 mL/sec, n=286, 287Month 12, >= 3 %, n=286, 287Month 18, >= 3 mL/sec, n=287, 288Month 18, >= 3 %, n= 287, 288Month 24, >= 3 mL/sec, n=287, 290Month 24, >= 30 %, n=287, 290
Dut 0.5 mg + Tam 0.2 mg8686102107115111121119
Placebo + Tam 0.2mg6970647380817771

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Number of Participants With Suicidal Ideation and Suicidal Behavior

Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: 6, 12, 18 , 24 months and final assessment

,
InterventionParticipants (Count of Participants)
Month 6, Suicidal ideation, Q1, n=289, 285Month 6, Suicidal ideation, Q2, n=289, 285Month 6, Suicidal behavior, Q6, n=289, 285Month 6, Suicidal behavior, Q7, n=289, 285Month 6, Suicidal behavior, Q8, n=289, 285Month 6, Suicidal behavior, Q9, n=289, 285Month 6, Suicidal behavior, Q10, n=289, 285Month 12, Suicidal ideation, Q1, n=279, 273Month 12, Suicidal ideation, Q2, n=279, 273Month 12, Suicidal behavior, Q6, n=279, 273Month 12, Suicidal behavior, Q7, n=279, 273Month 12, Suicidal behavior, Q8, n=279, 273Month 12, Suicidal behavior, Q9, n=279, 273Month 12, Suicidal behavior, Q10, n=279, 273Month 24, Suicidal ideation, Q1, n=261, 251Month 24, Suicidal ideation, Q2, n=261, 251Month 12, Suicidal behavior, Q6, n=261, 251Month 12, Suicidal behavior, Q7, n=261, 251Month 12, Suicidal behavior, Q8, n=261, 251Month 12, Suicidal behavior, Q9, n=261, 251Month 12, Suicidal behavior, Q10, n=261, 251Final assessment, Suicidal ideation,Q1, n=288, 285Final assessment, Suicidal ideation,Q2, n=288, 285Final assessment, Suicidal behavior,Q6, n=288, 285Final assessment, Suicidal behavior,Q7, n=288, 285Final assessment, Suicidal behavior,Q8, n=288, 285Final assessment, Suicidal behavior,Q9, n=288, 285Final assessment, Suicidal behavior,Q10,n=288, 285
Dut 0.5 mg + Tam 0.2 mg0000000000000010000001000000
Placebo + Tam 0.2mg0000000000000000000000000000

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Number of Participants With Threshold Clinical Chemistry Value.

Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
albumin, <0.90 X LLN, n=289, 292albumin, >1.20 X ULN, n=289, 292ALT, >3.00 X ULN, n=289, 292ALP, > 1.50 X ULN, n=289, 292AST, >3.00 X ULN, n=288, 292creatinine, <0.50 X LLN, n=289, 292creatinine, >3.00 X ULN, n=289, 292glucose, <0.70 X LLN, n=288, 292glucose, >1.75 X ULN, n=280, 285potassium, <0.75 X LLN, n=288, 292potassium, >1.40 X ULN, n=288, 292sodium, <0.90 X LLN, n=289, 292sodium, >1.15 X ULN, n=289, 292total bilirubin, >2.50 X ULN, n=289, 292total protein, <0.80 X LLN, n=289, 292total protein, >1.15 X ULN, n=289, 292Urea/BUN, <0.50 X LLN, n=289, 292Urea/BUN, >2.00 X ULN, n=289, 292
Dut 0.5 mg + Tam 0.2 mg0000100013000000000
Placebo + Tam 0.2mg0000000013000000000

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Number of Participants With Threshold Hematology Value.

The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
Hgb, <0.75 X LLN, n=287, 291Platelet count, <0.75 X LLN, n=284, 283Platelet count, >1.50 X ULN, n=285, 285RBC, <0.50 X LLN, n=287, 291WBC, <0.50 X LLN, n=287, 291WBC, >3.00 X ULN, n=287, 291
Dut 0.5 mg + Tam 0.2 mg010000
Placebo + Tam 0.2mg060000

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Number of Participants With Vital Signs Exceeding Threshold Values

Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from < 80 mmHg (millimeter of mercury) (lower) to > 165 mmHg (upper); for DBP ranged from < 40 mmHg (lower) to > 105 mmHg (upper) and heart rate < 40 beats per minute (bpm) (lower) to > 100 bpm (upper). (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
SBP, < 80 mmHgSBP, > 165 mmHgSBP, either thresholdDBP, < 40 mmHgDBP, > 105 mmHgDBP, either thresholdHeart rate, < 40 bpmHeart rate, > 100 bpmHeart rate, either threshold
Dut 0.5 mg + Tam 0.2 mg0131302201414
Placebo + Tam 0.2mg0101006601111

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Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)

PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Baseline, 12 and 24 Months

,
InterventionScores on scale (Mean)
Month 12, n=291, 293Month 24, n=291, 294
Dut 0.5 mg + Tam 0.2 mg-0.91-0.82
Placebo + Tam 0.2mg0.11-0.11

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Change From Baseline in Serum Prostate Specific Antigen (PSA)

Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Baseline 6, 12 and 24 Months

,
Interventionnanogram/milliliter (ng/mL) (Mean)
Month 6, n=292, 294Month 12, n=293, 294Month 24, n=293, 295
Dut 0.5 mg + Tam 0.2 mg-1.7-1.9-2.0
Placebo + Tam 0.2mg0.20.20.7

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Number of Participants With Clinically Significant Qualitative Breast Examination

Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: 6, 12, 18 , 24 months and final assessment

,
InterventionParticipants (Count of Participants)
Palpable breast tissue, Month 6, n=289, 284Nipple tenderness,Month 6, n=289, 284Palpable breast tissue, Month 12, n=279, 273Nipple tenderness,Month 12, n=279, 273Palpable breast tissue, Month 18, n=267, 258Nipple tenderness,Month 18, n=267, 258Palpable breast tissue, Month 24, n=262, 252Nipple tenderness, Month 24, n=262, 252Palpable breast tissue,final assessment, n=296,296Nipple tenderness,final assessment, n=296, 296
Dut 0.5 mg + Tam 0.2 mg0021000000
Placebo + Tam 0.2mg0010100000

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Number of Hospitalization Days

Duration of hospitalization days due to AUR or BPH-related surgery was recorded. (NCT02058368)
Timeframe: Up to 24 Months

InterventionDays (Median)
Placebo + Tam 0.2mg10.0
Dut 0.5 mg + Tam 0.2 mg9.0

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Change From Baseline in BPH Impact Index (BII) by LOCF Approach

The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches. (NCT02058368)
Timeframe: Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months

,
InterventionScores on scale (Mean)
Month 3, n=299, 296Month 6, n=300, 298Month 9, n=300, 298Month 12, n=300, 298Month 15, n=300, 298Month 18, n=300, 298Month 21, n=300, 298Month 24, n=300, 298
Dut 0.5 mg + Tam 0.2 mg-1.23-1.08-1.26-1.24-1.41-1.28-1.27-1.48
Placebo + Tam 0.2mg-1.48-1.28-1.55-1.39-1.30-1.16-1.12-1.02

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Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value. (NCT02058368)
Timeframe: Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

,
InterventionScore on scale (Mean)
Month 3, n=299, 296Month 6, n=300, 298Month 9, n=300, 298Month 12,n= 300, 298Month 15, n=300, 298Month 18, n=300, 298Month 21, n=300, 298Month 24, n=300, 298
Dut 0.5 mg + Tam 0.2 mg-3.28-3.36-4.28-4.30-4.90-4.54-4.66-4.96
Placebo + Tam 0.2mg-4.07-3.73-4.14-3.93-3.95-3.84-3.94-3.53

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Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach

Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Baseline, 6, 12, 18 and 24 Months

,
Interventionmilliliter per second (mL/sec) (Mean)
Month 6, n=270, 274Month 12, n=286, 287Month 18, n=287, 288Month 24, n=287,290
Dut 0.5 mg + Tam 0.2 mg1.541.622.362.27
Placebo + Tam 0.2mg0.620.630.900.93

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Number of Participants in a Hospital Ward

Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others (NCT02058368)
Timeframe: Up to 24 Months

,
InterventionParticipants (Count of Participants)
General wardRecoveryOther
Dut 0.5 mg + Tam 0.2 mg010
Placebo + Tam 0.2mg201

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Change From Baseline in Post Void Residual Volume

Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. (NCT02058368)
Timeframe: Baseline, 6, 12, 18 and 24 Months

,
InterventionmL (Mean)
Month 6, n=288, 290Month 12, n=291, 292Month 18, n=291, 292Month 24, n=291, 292
Dut 0.5 mg + Tam 0.2 mg-3.0-1.4-1.3-2.6
Placebo + Tam 0.2mg-4.81.5-2.62.6

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λz

"Terminal elimination rate constant in plasma (λz).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV." (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Intervention1/hours (Geometric Mean)
New MR (Test)0.05
Registered MR (Reference)0.05

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(AUC0-inf)

"Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV." (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Interventionh*pg/mL (Geometric Mean)
New MR (Test)248200
Registered MR (Reference)244700

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AUC0-tz

"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV." (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Interventionh*pg/mL (Geometric Mean)
New MR (Test)241500
Registered MR (Reference)238200

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Cmax

Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Interventionpg/mL (Geometric Mean)
New MR (Test)21700
Registered MR (Reference)20520

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t1/2

"Apparent terminal elimination half-life of the analyte in plasma (t1/2)~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV." (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

InterventionHours (Geometric Mean)
New MR (Test)13.10
Registered MR (Reference)13.52

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Tmax

Time to maximum plasma concentration (NCT02417831)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

InterventionHours (Median)
New MR (Test)5.004
Registered MR (Reference)5.006

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Terminal Elimination Rate Constant (λz)

Terminal elimination rate constant in plasma (λz) (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Intervention1/hour (Geometric Mean)
Tamsulosin HCl (Test)0.05
Flomax Relief (Reference)0.05

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Maximum Measured Concentration (Cmax)

Maximum measured concentration of analyte in plasma (Cmax) (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Interventionpg/mL (Geometric Mean)
Tamsulosin HCl (Test)8826
Flomax Relief (Reference)8856

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Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Interventionh*pg/mL (Geometric Mean)
Tamsulosin HCl (Test)164700
Flomax Relief (Reference)165400

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Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)

Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Interventionh*pg/mL (Geometric Mean)
Tamsulosin HCl (Test)170100
Flomax Relief (Reference)171000

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Apparent Terminal Elimination Half-life (t1/2)

Apparent terminal elimination half-life of the analyte in plasma (t1/2) (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Interventionhours (Geometric Mean)
Tamsulosin HCl (Test)13.16
Flomax Relief (Reference)13.21

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Time to Maximum Plasma Concentration (Tmax)

Time from last dosing to the maximum plasma concentration (tmax). (NCT02417844)
Timeframe: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

InterventionHours (Median)
Tamsulosin HCl (Test)7.51
Flomax Relief (Reference)8.00

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First Post-void Residual Urine Volume

The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void (NCT02486653)
Timeframe: within 0-7 days after surgery

InterventionmL (Mean)
Tamsulosin218
Placebo154

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Hospital Length of Stay in Days

Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital (NCT02486653)
Timeframe: up to 30 days after surgery

Interventiondays (Mean)
Tamsulosin6.4
Placebo6.0

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Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome

need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters (NCT02486653)
Timeframe: within 0-7 days after surgery

InterventionParticipants (Count of Participants)
Tamsulosin18
Placebo22

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Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome

Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours (NCT02486653)
Timeframe: within 0-7 days after surgery

InterventionParticipants (Count of Participants)
Tamsulosin5
Placebo5

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Number of Participants Who Experienced Adverse Events

Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting. (NCT02486653)
Timeframe: treatment day 1 (7 days before surgery) until 30 days after surgery

,
InterventionParticipants (Count of Participants)
Serious Adverse EventsOther Adverse Events
Placebo58
Tamsulosin310

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Total Number of Intermittent Catheterizations Required Per Subject

total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol (NCT02486653)
Timeframe: within 0-7 days after surgery

,
InterventionParticipants (Count of Participants)
At least 1 catheterizationAt least 2 catheterizationsgreater than 2 catheterizations
Placebo22105
Tamsulosin1880

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Urinary Tract Infection (UTI)

Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery (NCT02486653)
Timeframe: up to 30 days after surgery

InterventionParticipants (Count of Participants)
Tamsulosin0
Placebo1

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Discharge From Hospital With Indwelling Urinary Catheter

Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function. (NCT02486653)
Timeframe: up to 30 days after surgery

InterventionParticipants (Count of Participants)
Tamsulosin0
Placebo0

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Incidence of Postoperative Complications

Postoperative complications will be recorded and the incidence will be compared statistically between the two groups. (NCT02518971)
Timeframe: Up to 31 days postoperative

InterventionParticipants (Count of Participants)
Tamsulosin2
Placebo2

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Acute Postoperative Pain Medication Dosages

The dosages of postoperative pain medications will be compared statistically between the two groups. (NCT02518971)
Timeframe: Postoperative day 1 to day of discharge (1-4 days on average)

Interventionmorphine equivalent doses (Mean)
Tamsulosin44.85
Placebo36

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Incidence of Discharge to a Skilled Nursing Facility

Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups. (NCT02518971)
Timeframe: 1-4 days postoperative

InterventionParticipants (Count of Participants)
Tamsulosin1
Placebo1

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Incidence of Surgical Site Infection

Surgical site infection will be recorded (yes/no) and compared statistically between the two groups. (NCT02518971)
Timeframe: Up to two weeks postoperative

InterventionParticipants (Count of Participants)
Tamsulosin0
Placebo2

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Length of Hospital Stay

Length of hospital stay will be recorded in days and compared statistically between the two groups . (NCT02518971)
Timeframe: 1-4 days postoperative

Interventiondays (Mean)
Tamsulosin1.125
Placebo1.209

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Number of Patients to Develop Postoperative Urinary Retention (POUR)

Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery. (NCT02518971)
Timeframe: Postop day 1

InterventionParticipants (Count of Participants)
Tamsulosin18
Placebo24

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Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1

Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval (NCT02573311)
Timeframe: Week 12 and Week 24

InterventionPercentage of participants (Number)
Week 12 (N=924)Week 24 (N=924)
Cohort 143.156.4

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"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1"

"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: 24 weeks

InterventionPercentage of participants (Number)
Cohort 10.2

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"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1"

"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Cohort 10.2

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"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1"

"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval" (NCT02573311)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Cohort 122.4

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"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks"

"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Cohort 10.9

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"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1"

"Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: 24 weeks

InterventionPercentage of participants (Number)
Cohort 120.3

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Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1

Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval (NCT02573311)
Timeframe: Week 12 and Week 24

InterventionPercentage of participants (Number)
Week 12 (N=924)Week 24 (N=924)
Cohort 17.69.5

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"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks"

"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Cohort 11.0

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"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition"

"Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval." (NCT02573311)
Timeframe: 24 weeks

InterventionPercentage of participants (Number)
Cohort 184.3

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Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionincontinence episodes (Mean)
Placebo-0.72
Mirabegron 50mg-0.77

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Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)

Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time). (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo0.20
Mirabegron 50mg-0.25

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Change From Baseline to EoT in Mean Number of Nocturia Episodes

A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionnocturia episodes (Mean)
Placebo-0.35
Mirabegron 50mg-0.31

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Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours

An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionurgency episodes (Mean)
Placebo-1.66
Mirabegron 50mg-1.89

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Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionurgency incontinence episodes (Mean)
Placebo-0.65
Mirabegron 50mg-0.75

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Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo2.632
Mirabegron 50mg14.995

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Change From Baseline to EoT in Postvoid Residual (PVR) Volume

PVR was measured by ultrasonography. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

InterventionmL (Mean)
Placebo-0.97
Mirabegron 50mg2.72

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Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)

"The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.~Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-11.53
Mirabegron 50mg-16.09

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Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)

The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-2.2
Mirabegron 50mg-2.8

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Change From Baseline to EoT in IPSS Subscale Scores

IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

,
Interventionunits on a scale (Mean)
Storage SubscaleVoiding Subscale-1Voiding Subscale-2Quality of Life Item
Mirabegron 50mg-2.4-1.4-2.0-1.2
Placebo-1.7-1.3-1.7-0.9

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Change From Baseline to EoT in OABSS Subscale Scores

"Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement." (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

,
Interventionunits on a scale (Mean)
Daytime FrequencyNighttime FrequencyUrgencyUrgency Incontinence
Mirabegron 50mg-0.3-0.3-1.5-0.7
Placebo-0.2-0.2-1.3-0.4

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Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and week 4, 8 and 12

,
Interventionmicturitions (Mean)
Week 4Week 8Week 12
Mirabegron 50mg-0.55-0.76-1.36
Placebo-0.08-0.36-0.92

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Number of Participants With Adverse Events

Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious. (NCT02656173)
Timeframe: From first dose of study drug up to Week 12

,
InterventionParticipants (Count of Participants)
Any TEAEsMildModerateSevereDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEsTEAEs leading to discontinuation of study drugDrug-related TEAEs leading to disc. of study drug
Mirabegron 50mg6656821106040
Placebo6457611803143

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Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)

The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionunits on a scale (Mean)
Placebo-3.4
Mirabegron 50mg-4.4

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Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit. (NCT02656173)
Timeframe: Baseline and EoT (up to 12 weeks)

Interventionmicturitions (Mean)
Placebo-0.90
Mirabegron 50mg-1.35

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Number of Participants With Post-operative Urinary Retention

(NCT02684344)
Timeframe: 5 days

InterventionParticipants (Count of Participants)
Tamsulosin Group0
Education Group0

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Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day

Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Week 12

Interventionmicturitions per day (Least Squares Mean)
Mirabegron-2.00
Placebo-1.62

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)

The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

Interventionunits on a scale (Least Squares Mean)
MirabegronNA
PlaceboNA

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Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day

Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionmicturitions per day (Least Squares Mean)
Week 4Week 8Week 12
Mirabegron-1.42-1.89-1.95
Placebo-1.32-1.38-1.56

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities

The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). Health-state utility (HSU) data are estimates of the preference for a given state of health on a cardinal numeric scale, where a value of 1.0 represents full health, 0.0 represents dead, and negative values represent states worse than death. Missing EoT values were imputed using LOCF method. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12EoT
Mirabegron0.0110.0190.0280.026
Placebo0.0190.0300.0320.034

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron9.0613.3415.6414.81
Placebo10.8712.9914.4714.67

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron10.5816.0118.9318.05
Placebo12.4715.2518.0318.02

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron10.4315.3217.9416.87
Placebo10.4514.4116.4116.62

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score

The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron5.558.039.488.96
Placebo6.658.359.579.67

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.9-1.3-1.5-1.4
Placebo-0.7-1.1-1.3-1.3

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-1.7-2.2-2.5-2.5
Placebo-2.1-2.5-2.5-2.6

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionincontinence episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.97-1.29-1.48-1.45
Placebo-0.84-1.20-1.23-1.15

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionnocturia episodes per 24 hours (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.32-0.48-0.51-0.49
Placebo-0.45-0.55-0.52-0.52

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

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Interventionurgency episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-1.79-2.68-2.86-2.90
Placebo-1.53-1.97-2.21-2.24

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-3.9-5.0-5.9-5.7
Placebo-4.0-5.2-5.5-5.6

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition during 3 days of the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

,
InterventionmL per micturition (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron17.7422.5626.3125.57
Placebo13.8716.2817.3216.32

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)

The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

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Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.6-0.8-1.0-0.9
Placebo-0.5-0.7-0.9-0.9

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score

Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). Lower scores on OAB-q symptom bother indicate a better response. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

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Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-13.73-18.72-20.93-20.18
Placebo-11.98-14.88-18.03-18.07

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

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Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron15.618.619.118.4
Placebo12.516.116.916.9

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Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score

The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8, and 12

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Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-2.2-2.8-3.3-3.3
Placebo-1.9-2.6-3.0-3.0

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Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day

Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. (NCT02757768)
Timeframe: Baseline and Weeks 4, 8 and 12

,
Interventionurgency incontinence episodes per day (Least Squares Mean)
Week 4Week 8Week 12EoT
Mirabegron-0.97-1.29-1.52-1.49
Placebo-0.85-1.19-1.24-1.16

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Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention

Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed. (NCT02919436)
Timeframe: Within 2 days after surgery

InterventionParticipants (Count of Participants)
Tamsulosin23
Placebo25

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Length of Stay

Length of hospital stay (NCT02919436)
Timeframe: 0-7 days after surgery

Interventiondays (Mean)
Tamsulosin0.9
Placebo0.7

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International Prostate Symptom Score

Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst) (NCT03524339)
Timeframe: Within 1 week of surgery

InterventionPoints (Median)
Placebo6
Tamsulosin7

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Sent Home With Catheterization

Urinary retention that required homegoing catheterization (NCT03524339)
Timeframe: within 6 weeks of surgery

InterventionParticipants (Count of Participants)
Placebo7
Tamsulosin5

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Postoperative Urinary Tract Infection

Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection. (NCT03524339)
Timeframe: Within 6 weeks after surgery

InterventionParticipants (Count of Participants)
Placebo6
Tamsulosin4

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Postoperative Urinary Retention

Failed voiding trial upon removal of catheter (NCT03524339)
Timeframe: Within 72 hours of surgery

InterventionParticipants (Count of Participants)
Placebo16
Tamsulosin5

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