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1 | Completion Date | Registration number | Study Types | Included in the analysis: 1 = Yes | 0 = No | Funded Bys | Phases | PMID or publication URL | Follow-up time (weeks) | Excludes patients with risk factors for hypotension? Yes= 1 | No = 0 | Combination with another hypotensive drug? Yes= 1 | No = 0 | Cardiovascular variables assesed? (see comments) | Cardiovascular variables reported? Yes= 1 | No = 0 | Final sample size | Enrollment | Study Designs | Interventions | Title | Results First Received | Conditions | Recruitment | Sponsor/Collaborators | Start Date | First Received | Start Date - First Received (days) | Age Groups | Outcome Measures | Other IDs | Acronym | |||
2 | 01/03/2012 | NCT01495026 | Interventional | 1 | Industry | Phase 1 | 24615171 | 2 | 1 | 0 | 2 | A | 0 | 40 | 63 | Allocation: Randomized|Endpoint Classification: Bio-equivalence Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Open Label | Drug: Dutasteride (0.5mg, fasted state)|Drug: Dutasteride (0.5mg, fed state)|Drug: Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|Drug: Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|Drug: Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|Drug: Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fed state)|Drug: Harnal-D Tablets with water (fasted state)|Drug: Harnal-D Tablets with water (fed state)|Drug: Harnal-D tablets without water (fasted state) | A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia | No Study Results Posted | Prostatic Hyperplasia | Completed | GlaxoSmithKline | 11/1/2011 | 12/15/2011 | -44 | Adult | Relative bioavailability of tamsulosin from FDC products (0.5 mg dutasteride /0.2 mg tamsulosin HCl) containing a size 3-oblong dutasteride soft gel capsule and tamsulosin pellets having a range of tamsulosin release rates produced by different mixtures|Effect of food on the relative bioavailability of tamsulosin in a selected FDC product in healthy male subjects of North East Asian ancestry|Effect of water on the relative bioavailability of tamsulosin in Harnal-D Tablets in the fasted state in healthy male subjects of North East Asian ancestry.|Safety and tolerability of dosing with the different FDC capsule formulations in healthy male subjects of North East Asian ancestry | 115708 | ||||
3 | 01/12/2010 | NCT01254071 | Interventional | 1 | Industry | Phase 1 | 24615171 | 0,4 | 1 | 0 | 2 | A | 0 | 86 | 86 | Allocation: Randomized|Endpoint Classification: Bio-availability Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Open Label | Drug: Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg) | A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. | No Study Results Posted | Prostatic Hyperplasia | Completed | GlaxoSmithKline | 9/1/2010 | 12/2/2010 | -92 | Adult | 1. To investigate the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets in the fed and fasted states.|1. To investigate the effect of food on the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets. | 114694 | ARI114694 | |||
4 | 01/09/2011 | NCT01471678 | Interventional | 1 | Industry | Phase 1 | 24615171 | 0,4 | 1 | 0 | 2 | A | 0 | 26 | 27 | Allocation: Randomized|Endpoint Classification: Bio-availability Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Open Label | Drug: Dutasteride (0.5mg)|Drug: FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg)|Drug: Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl) | Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. | No Study Results Posted | Prostatic Hyperplasia | Completed | GlaxoSmithKline | 6/1/2011 | 10/13/2011 | -134 | Adult | Bioavailability of tamsulosin in 2 FDC formulations (Tamsulosin 0.2 mg and Dutasteride 0.5 mg) relative to co-administration of AVODART capsules with Harnal-D tablets or Harnal capsules in male subjects of Asian ancestry in the fed state|Bioavailability of tamsulosin in one FDC formulation relative to the other FDC formulation (each capsule containing 0.2 mg tamsulosin HCl and 0.5 mg dutasteride) in healthy male subjects of Asian ancestry in the fed state.|Safety and tolerability of dosing with one FDC formulation relative to the other FDC formulation (each capsule containing 0.2 mg tamsulosin HCl and 0.5 mg dutasteride) in healthy male subjects of Asian ancestry in the fed state | 115707 | ARI115707 | |||
10 | 01/09/2007 | NCT00510406 | Interventional | 1 | Industry | Phase 2 | 23537687 | 12 | 0 | 0 | 0 | 0 | 919 | 919 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: tamsulosin hydrochloride|Drug: solifenacin succinate|Drug: Placebo | A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH | No Study Results Posted | Lower Urinary Tract Symptoms|Prostatic Hyperplasia | Completed | Astellas Pharma Inc | 1/1/2007 | 7/31/2007 | -211 | Adult|Senior | Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH|Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride | 905-CL-052|EudraCT number: 2006-002072-18 | SATURN | |||
15 | 01/03/2011 | NCT01018511 | Interventional | 1 | Industry | Phase 3 | 23932438 | 12 | 0 | 0 | 0 | 0 | 1225 | 1334 | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Placebo|Drug: tamsulosin hydrochloride monotherapy|Drug: tamsulosin hydrochloride / solifenacin succinate fixed dose combinations | Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms | No Study Results Posted | Lower Urinary Tract Symptoms|Benign Prostatic Hyperplasia | Completed | Astellas Pharma Inc | 1/1/2010 | 11/19/2009 | 43 | Adult|Senior | Change from baseline to endpoint in total International Prostate Symptom Score|Change from baseline to endpoint in TUS|Change from baseline to endpoint in data from micturition diary, I-PSS questionnaire, OAB-q, EQ-5D, PGI and CGI|Safety variables|PK variables | 905-CL-055|2008-001211-37 | Neptune | |||
24 | 01/08/2008 | NCT00507455 | Interventional | 1 | Industry | Phase 2 | 22831853 | 12 | 1 | 0 | 0 | 0 | 192 | 222 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator) | Drug: solifenacin succinate|Drug: tamsulosin hydrochloride|Drug: placebo | Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction | No Study Results Posted | Lower Urinary Tract Symptoms|Bladder Outlet Obstruction | Completed | Astellas Pharma Inc | 6/1/2007 | 7/25/2007 | -54 | Adult|Senior | Evaluate the urodynamic variables|Tolerability, safety, and efficacy of 2 doses of solifenacin succinate with tamsulosin hydrochloride | 905-CL-058 | ||||
33 | 01/12/2011 | NCT01209988 | Interventional | 1 | Other|Industry | Phase 2 | 23906190 | 4 | 0 | 0 | 0 | 0 | 218 | 220 | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Single Blind (Investigator) | Drug: tamsulosin 0.4mg|Other: No medication | Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy | No Study Results Posted | Prostatic Neoplasms, Prostatectomy | Recruiting | Asan Medical Center|Astellas Pharma Inc | 4/1/2010 | 9/27/2010 | -179 | Child|Adult|Senior | The incidence of acute urinary retention|Patient reported outcomes | AMC_UR_010 | ||||
36 | 01/12/2010 | NCT01215708 | Interventional | 1 | Other | Phase 3 | 21802124 | 4 | 1 | 0 | 0 | 0 | 111 | 136 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Tamsulosin | Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus | No Study Results Posted | Renal Calculi | Active, not recruiting | University of Sao Paulo General Hospital|Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | 8/1/2006 | 10/5/2010 | -1526 | Adult|Senior | To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL|To evaluate the effects of Tamsulosin and Nifedipine in the episodes of pain after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL|To evaluate the effects of Tamsulosin and Nifedipine in the velocity of elimination of fragments after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL | 278/06 | ||||
39 | 01/12/2006 | NCT00151567 | Interventional | 1 | Other | Phase 3 | 21149761 | 6 | 1 | 0 | 2 | C | 1 | 121 | 129 | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Tamsulosin|Drug: Placebo | Evaluation of Tamsulosin in the Treatment of Ureteral Stones | No Study Results Posted | Ureterolithiasis|Ureteral Calculi | Completed | Rennes University Hospital|Ministry of Health, France|Yamanouchi | 2/1/2002 | 9/8/2005 | -1315 | Adult|Senior | Time to stone elimination in days (censored criterion)|Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)|Pain using Visual Analogue Scale|Spontaneous stone elimination rate|Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)|Rate of need for surgery|Time to surgery in days in patients with surgical elimination|Rate of pain recurrences|Time to the first recurrence in days|Rate of need for corticoids or morphine|Time to the first administration of corticoids or morphine in days|Rate of adverse events | AFSSAPS 010751|PHRC/00-01|CIC0203/004 | TAMSULOSINE | |||
41 | 01/11/2008 | NCT00831701 | Interventional | 1 | Other | Phase 2 | 19375849 | 3 | 1 | 0 | 0 | 0 | 90 | 100 | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Tamsulosin|Drug: Placebo | Medical Expulsive Therapy of Single Distal Ureteral Stones | 11/01/2010 | Ureteral Calculi | Completed | University of Zurich | 9/1/2006 | 11/19/2008 | -810 | Adult|Senior | Number of Participants With Stone Expulsion|Time to Stone Passage|Required Analgesics|Maximum Daily Pain Score|Number of Participants Requiring Active Treatment | 1-Hermanns | ||||
48 | 01/09/2010 | NCT01076309 | Observational | 1 | Other | Observational | 23617291 | 12 | 0 | 0 | 0 | 0 | 48 | 60 | Observational Model: Case Control|Time Perspective: Prospective | Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin | No Study Results Posted | Cataract | Completed | Frederiksberg University Hospital | 6/1/2009 | 2/25/2010 | -269 | Child|Adult|Senior | corneal endothelium cell loss | FH4 | |||||
50 | 01/09/2009 | NCT00090103 | Interventional | 1 | Industry | Phase 3 | 21093145 | 19825505 | 22425127 | 224 | 1 | 0 | 0 | 0 | 3572 | 4844 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) | Drug: dutasteride 0.5mg once daily for 4 years|Drug: tamsulosin 0.4mg once daily for 4 years | Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment | 26/02/2010 | Prostatic Hyperplasia | Completed | GlaxoSmithKline | 11/1/2003 | 8/24/2004 | -297 | Adult|Senior | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.|Number of Participants With AUR or BPH-related Surgery|Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4|The Number of Participants With Each of the Five Components of BPH Clinical Progression|Number of Events of Symptom Deterioration at the Indicated Time Periods|Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria|Number of Participants With an Event of Post-baseline BPH-related Hematospermia|Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48|Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48|Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48|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|Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit|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"?.|Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit|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?"|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.)|Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48|Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | ARI40005 | ||||
61 | 01/01/2010 | NCT00771394 | Interventional | 1 | Industry | Phase 4 | 21601248 | 12 | 1 | 0 | 0 | 0 | 591 | 638 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Tamsulosin hydrochloride|Drug: Solifenacin succinate | Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia | No Study Results Posted | Benign Prostatic Hyperplasia|Benign Prostatic Hypertrophy|Overactive Bladder | Completed | Astellas Pharma Inc | 10/1/2008 | 10/9/2008 | -8 | Adult|Senior | Change from baseline in mean number of urgency episodes per 24 hours|Mean number of micturitions per 24 hrs|Mean number of incontinence episodes per 24 hours|Mean number of micturitions per night|Adverse Events, Laboratory Tests | 905-JC-001 | ||||
63 | 01/09/2010 | NCT00606983 | Interventional | 1 | Other | Phase 3 | 22806208 | 1 | 0 | 0 | 0 | 0 | 94 | 100 | Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator) | Drug: Tamsulosin | Prevention of Acute Voiding Difficulty After Radical Proctectomy | No Study Results Posted | Rectal Cancer|Urinary Retention | Completed | Seoul National University Hospital | 5/1/2007 | 1/22/2008 | -266 | Adult|Senior | Re-insertion rate of urinary catheter after removal|Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry | B-0702-042-006|SNUBH-GS-CR3 | ||||
66 | 01/12/2012 | NCT01252472 | Observational | 1 | Other | Observational | 24631201 | N/A: Cross-Sectional | 0 | 0 | 0 | 0 | 30 | 30 | Observational Model: Case Control|Time Perspective: Cross-Sectional | Flomax Study for Floppy Iris Syndrome | No Study Results Posted | Floppy Iris Syndrome | Recruiting | University of Michigan | 6/1/2010 | 12/2/2010 | -184 | Adult|Senior | HUM00039333 | ||||||
68 | 01/03/2008 | NCT00602186 | Interventional | 1 | Other | Phase 1|Phase 2 | 21403790 | 12 | 0 | 0 | 0 | 0 | 37 | 80 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Outcomes Assessor) | Drug: tamsolusin|Drug: prazosin | Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction | No Study Results Posted | Neurogenic Bladder | Active, not recruiting | Tabriz University | 7/1/2005 | 4/18/2007 | -656 | Adult|Senior | patient symptoms improvement(Standard questionare)|Urodynamics parameters improvement | 85-1 | ||||
69 | 01/05/2006 | NCT00147654 | Interventional | 1 | Industry | Phase 4 | 17105794 | 12 | 0 | 0 | 0 | 0 | 851 | 830 | Allocation: Randomized|Endpoint Classification: Safety Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double-Blind | Drug: Tolterodine ER 4 mg QD|Drug: Tamsulosin 0.4 mg QD | Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction | No Study Results Posted | Urinary Incontinence | Completed | Pfizer | 11/1/2004 | 9/2/2005 | -305 | Adult|Senior | Patient Perception of Treatment Benefit at Week 12:|Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12|Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.|Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.|Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.|Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline|Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline|Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline|Change in number of OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline|Change in number of daytime OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline|Change in number of nighttime OAB micturition episodes per 24 hours. (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline|Change in number of severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline|Change in number of daytime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline|Change in number of nighttime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline|International Prostate Symptom Score (I-PSS):|Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline|Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline|Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline|Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline|Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline|Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline|Patient perception of urgency:|Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline|Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline|Patient Perception of Treatment benefit at week 1 and week 6|Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6|Change in International Continence Society Male (ICSmaleLF) Questionnaire (long form modified) individual item scores at Week 1, Week 6 and Week 12 relative to baseline|Change in the total score of Overactive Bladder Questionnaire (OABq) and change in total scores for each domain of OABq at week 6 and week 12 relative to baseline|Change in the total score of International Index of Erectile Function (IIEF) and change in total scores for each domain of IIEF Questionnaire at week 6 and week 12 relative to baseline | A6121120 | ||||
70 | 01/01/2008 | NCT00359905 | Interventional | 1 | Industry | Phase 3 | 21109344 | 52 | 1 | 0 | 0 | 0 | 892 | 1228 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Silodosin|Drug: Tamsulosin|Drug: Placebo | Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH | No Study Results Posted | Benign Prostatic Hyperplasia | Completed | Recordati Industria Chimica e Farmaceutica S.p.A. | 5/1/2006 | 8/2/2006 | -93 | Adult|Senior | Change in baseline total score on the International Prostate Symptom Score|Change in baseline obstructive subscore of the International Prostate Symptom Score;|change in baseline irritative subscore of the International Prostate Symptom Score;|change in baseline maximum urine flow rate;|safety | KMD3213-IT-CL 0215 | ||||
71 | 01/06/2010 | NCT00861757 | Interventional | 1 | Industry | Phase 3 | 22958078 | 23134716 | 12 | 1 | 1 | 2 | A | 1 | 611 | 612 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) | Drug: Tadalafil|Drug: Placebo|Drug: Tamsulosin | Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia | 10/05/2011 | Benign Prostatic Hyperplasia | Completed | Eli Lilly and Company | 3/1/2009 | 3/12/2009 | -11 | Adult|Senior | Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks|Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks|Patient Global Impression of Improvement (PGI-I) at Week 12|Clinician Global Impression of Improvement (CGI-I) at Week 12|Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|Change From Baseline in Blood Pressure (Sitting) at 12 Weeks|Change From Baseline in Blood Pressure (Standing) at 12 Weeks|Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks | 10487|H6D-MC-LVHB | ||||
78 | 01/06/2008 | NCT00540124 | Interventional | 1 | Industry | Phase 2 | 22468213 | 23134716 | http://onlinelibrary.wiley.com/doi/10.1111/j.1757-5672.2011.00088.x/full | 12 | 0 | 1 | 0 | 0 | 110 | 151 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator) | Drug: Tadalafil|Drug: Placebo|Drug: Tamsulosin | Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men | 01/06/2009 | Benign Prostatic Hyperplasia | Completed | Eli Lilly and Company | 10/1/2007 | 10/3/2007 | -2 | Adult|Senior | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)|Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies|Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies|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|Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary|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|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | 11658|H6D-MC-LVHT | ||||
79 | 01/01/2011 | NCT00970632 | Interventional | 1 | Industry | Phase 3 | 23346990 | 22297243 | 12 | 1 | 1 | 0 | 0 | 561 | 511 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Investigator, Outcomes Assessor) | Drug: Tadalafil 5 mg|Drug: Placebo tablet|Drug: Tamsulosin|Drug: Placebo capsule | A Study of Tadalafil in Men With Benign Prostatic Hyperplasia | 21/11/2011 | Benign Prostatic Hyperplasia (BPH) | Completed | Eli Lilly and Company | 10/1/2009 | 9/1/2009 | 30 | Adult|Senior | Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.|Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|Clinician Global Impression of Improvement (CGI-I) at 12 Weeks|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks|Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks|Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks|Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks | 12932|H6D-MC-LVID | ||||
87 | 01/04/2008 | NCT00457457 | Interventional | 1 | Industry | Phase 2 | 20184577 | 12 | 0 | 0 | 0 | 0 | 310 | 609 | Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Caregiver, Investigator) | Drug: Tamsulosin|Drug: UK-369,003 | Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms. | No Study Results Posted | Prostatic Hyperplasia | Completed | Pfizer | 5/1/2007 | 4/5/2007 | 26 | Adult|Senior | Change in international prostate symptom score|Erectile Function (EF) domain of International Index of Erectile|Function (IIEF)|Qmax|Quality of Erection questionnaire (QEQ)|Population pharmacokinetics | A3711044 | ||||
144 | 29/08/2012 | IRCT201109084582N5 | Interventional | 1 | Other | Phase 3 | http://www.scielo.br/scielo.php?pid=S1677-55382014000100030&script=sci_arttext&tlng=pt | 0,2 | 0 | 0 | 0 | 0 | 232 | 222 | Randomization: randomized. Blinding: Double blind. Placebo: used. Assignment: Parallel. Purpose: Prevention. Other design features: . | Intervention 1: 3 dose of tamsulosine capsule 0.4mg orally (2 dose during 14 and 2 hours before surgery and one dose 10 hours after surgery) . Intervention 2: 3 dose of placebo orally (2 dose during 14 and 2 hours before surgery and one dose 10 hours after surgery) . | Comparison of effectiveness of tamsulosin with placebo in prevention of urinary retention after scrotal surgeries, varicocelectomy and herniorrhaphy | Not Recruiting | Urology Research Center, Guilan University of Medical Sciences | 30/08/2011 | 27/11/2011 | -89 | Adult | urinary retention. Timepoint: during 24 hours after surgery. Method of measurement: Medical history, physical examination, urine volume after catheterization | |||||||
158 | ISRCTN85291415 | Interventional | 1 | Other | Phase 3 | 15492337 | 6 | 0 | 0 | 0 | 0 | 179 | 184 | Multicentre randomised double blind placebo controlled 2x2 factorial trial | A 2x2 factorial design assessing four interventions: ciprofloxacin alone, tamsulosin alone, the combination of ciprofloxacin and tamsulosin, and placebo. All treatments were provided for six weeks. Please note that as of 25/08/09 the start and end dates of this trial have been updated. The initial dates, 01/04/2002 to 30/04/2004, were generated at the time of registration. | A multicentre, randomised clinical trial to evaluate the efficacy of oral ciprofloxacin, oral tamsulosin, and the combination of oral ciprofloxacin and oral tamsulosin for the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome | Not recruiting | 1. National Institutes of Health (NIH) (USA) - cooperative agreements U01 DK53572, U01 DK53730, U01 DK53736, U01 DK53734, U01 DK53732, U01 DK53746, and U01 DK53738. 2. Boehringer Ingelheim (USA) - provided tamsulosin and matching placebo 3. Bayer Corporation (USA) - provided ciprofloxacin and matching placebo. | 1/7/2001 | 11/11/2004 | -1229 | Blank | Not provided at time of registration | N/A; | N/A | ||||||
163 | JPRN-UMIN000005012 | Interventional | 1 | Other | Phase 3 | 23953605 | 12 | 0 | 0 | 0 | 0 | 246 | 300 | Parallel Randomized | Tamsulosin 0.2mg will be orally administered once a day after breakfast and Imidafenacin 0.1mg will be administered orally twice a day, once after breakfast and dinner for 52 weeks.Tamsulosin 0.2mg will be orally administered once a day after breakfast for 12 weeks. | Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy. | Not Recruiting | Department of Urology, University of Yamanashi, School of Medicine / 1) Nihon Univ. 2) Shinshu Univ 3) Nagoya Univ. 4) Kumamoto Rosai Hospital 5) Sapporo Medical Univ. | 1/10/2010 | 2/4/2011 | -183 | Adult|Senior | Change of total OABSS score | ||||||||
169 | KCT0000117 | Interventional | 1 | Other|Industry | Phase 2 | 22921287 | 0,2 | 1 | 1 | 1 | A | 1 | 18 | 20 | Primary Purpose : Treatment, Intervention Model : Cross-over, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT | Drug : SK3530 100 mg or placebo was taken orally 3 hours the administration of tamsulosin 0.2 mg. | Clinical trial to investigate the influence of drug interaction after oral administration of tamsulosin and SK3530 | Not Recruiting | SK chemicals / SEOUL NATIONAL UNIVERSITY HOSPITAL | 7/5/2007 | 24/05/2011 | -1478 | Adult | SBP and DBP at supine and standing postion | ||||||||
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