Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 64 of 117 for:    DUTASTERIDE

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02058368
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostatic Hyperplasia
Interventions Drug: Dutasteride 0.5mg capsules
Drug: Dutasteride placebo capsules
Drug: Tamsulosin 0.2mg tablets
Drug: Disintegrating placebo tamsulosin tablet
Enrollment 607
Recruitment Details A randomized, double-blind, parallel group trial to assess the effectiveness and safety of dutasteride (Dut) 0.5 milligram (mg) and tamsulosin (Tam) 0.2 mg combination compared to Tam 0.2 mg. The study consisted of a single-blind, placebo run-in, followed by a 2 year treatment. Eligible subjects were randomized to Dut + Tam or Dut placebo + Tam
Pre-assignment Details Six hundred and fifty moderate to severe benign prostatic hyperplasia (BPH) subjects were screened with 607 participants receiving as least one dose of the study medication (China 243, Japan 135, Korea 181, Taiwan 48). Five hundred and twelve subjects completed the study with 95 subjects withdrawn.
Arm/Group Title Placebo +Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks. Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Period Title: Overall Study
Started 302 305
Completed 261 251
Not Completed 41 54
Reason Not Completed
Adverse Event             15             20
Lack of Efficacy             0             1
Protocol Violation             0             4
Lost to Follow-up             2             0
Physician Decision             2             3
Withdrawal by Subject             22             26
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg Total
Hide Arm/Group Description Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks. Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks. Total of all reporting groups
Overall Number of Baseline Participants 302 305 607
Hide Baseline Analysis Population Description
Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 302 participants 305 participants 607 participants
66.2  (6.85) 66.8  (6.82) 66.5  (6.84)
[1]
Measure Analysis Population Description: Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 305 participants 607 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
302
 100.0%
305
 100.0%
607
 100.0%
[1]
Measure Analysis Population Description: Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 305 participants 607 participants
Asian - East Asian Heritage
234
  77.5%
236
  77.4%
470
  77.4%
Asian - Japanese Heritage
68
  22.5%
67
  22.0%
135
  22.2%
Asian - Southeast Asian Heritage
0
   0.0%
2
   0.7%
2
   0.3%
[1]
Measure Analysis Population Description: Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
1.Primary Outcome
Title Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months
Hide Description 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.
Time Frame Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Error)
Unit of Measure: Score on scale
Month 3, n=299, 296 Number Analyzed 299 participants 296 participants
-4.07  (0.34) -3.28  (0.34)
Month 6, n=300, 298 Number Analyzed 300 participants 298 participants
-3.73  (0.37) -3.36  (0.37)
Month 9, n=300, 298 Number Analyzed 300 participants 298 participants
-4.14  (0.36) -4.28  (0.36)
Month 12,n= 300, 298 Number Analyzed 300 participants 298 participants
-3.93  (0.36) -4.30  (0.36)
Month 15, n=300, 298 Number Analyzed 300 participants 298 participants
-3.95  (0.36) -4.90  (0.36)
Month 18, n=300, 298 Number Analyzed 300 participants 298 participants
-3.84  (0.38) -4.54  (0.38)
Month 21, n=300, 298 Number Analyzed 300 participants 298 participants
-3.94  (0.38) -4.66  (0.38)
Month 24, n=300, 298 Number Analyzed 300 participants 298 participants
-3.53  (0.39) -4.96  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
-0.06 to 1.65
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-0.55 to 1.29
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-1.05 to 0.77
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-1.27 to 0.53
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.85 to -0.05
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.65 to 0.26
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.68 to 0.25
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.43
Confidence Interval (2-Sided) 95%
-2.40 to -0.46
Estimation Comments Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.
2.Secondary Outcome
Title Percent Change in Prostate Volume From Baseline
Hide Description 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.
Time Frame Baseline,12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Error)
Unit of Measure: Cubic centimeters (cc)
Month 12, n=287, 286 Number Analyzed 287 participants 286 participants
0.2  (1.28) -22.8  (0.99)
Month 24, n=287, 286 Number Analyzed 287 participants 286 participants
3.6  (1.45) -24.8  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.0
Confidence Interval (2-Sided) 95%
-25.9 to -20.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.48
Estimation Comments The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -28.4
Confidence Interval (2-Sided) 95%
-31.7 to -25.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.65
Estimation Comments The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24
3.Secondary Outcome
Title Number of Participants With IPSS Improvement From Baseline
Hide Description 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.
Time Frame Baseline and 3, 6, 9,12,15,18,21 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Number
Unit of Measure: Participants
Month 3,>= 3 units, n=299, 296 Number Analyzed 299 participants 296 participants
160 157
Month 3,>= 2 units, n=299,296 Number Analyzed 299 participants 296 participants
190 176
Month 3,>= 25percent, n=299, 296 Number Analyzed 299 participants 296 participants
134 123
Month 6,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
156 156
Month 6,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
179 176
Month 6,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
131 133
Month 9,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
157 177
Month 9,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
185 193
Month 9,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
128 150
Month 12,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
154 171
Month 12,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
179 191
Month 12,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
131 154
Month 15,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
171 186
Month 15,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
186 203
Month 15,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
133 160
Month 18,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
156 171
Month 18,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
173 187
Month 18,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
136 148
Month 21,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
169 178
Month 21,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
186 194
Month 21,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
141 161
Month 24,>= 3 units, n=300, 298 Number Analyzed 300 participants 298 participants
156 184
Month 24,>= 2 units, n=300, 298 Number Analyzed 300 participants 298 participants
175 197
Month 24,>= 25percent, n=300, 298 Number Analyzed 300 participants 298 participants
137 169
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments P-value for IPSS improvement >= 3 units has been presented for Month 3
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments P-value for IPSS improvement >= 2 units has been presented for Month 3
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 3
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments P-value for IPSS improvement >= 3 units has been presented for Month 6
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments P-value for IPSS improvement >= 2 units has been presented for Month 6
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 6
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments P-value for IPSS improvement >= 3 units has been presented for Month 9
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments P-value for IPSS improvement >= 2 units has been presented for Month 9
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 9
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments P-value for IPSS improvement >= 3 units has been presented for Month 12
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments P-value for IPSS improvement >= 2 units has been presented for Month 12
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 12
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments P-value for IPSS improvement >= 3 units has been presented for Month 15
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments P-value for IPSS improvement >= 2 units has been presented for Month 15
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 15
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments P-value for IPSS improvement >= 3 units has been presented for Month 18
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments P-value for IPSS improvement >= 2 units has been presented for Month 18
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 18
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments P-value for IPSS improvement >= 3 units has been presented for Month 21
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments P-value for IPSS improvement >= 2 units has been presented for Month 21
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 21
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments P-value for IPSS improvement >= 3 units has been presented for Month 24
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments P-value for IPSS improvement >= 2 units has been presented for Month 24
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value for IPSS improvement >= 25 percent has been presented for Month 24
Method Mantel Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach
Hide Description 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.
Time Frame Baseline, 6, 12, 18 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Error)
Unit of Measure: milliliter per second (mL/sec)
Month 6, n=270, 274 Number Analyzed 270 participants 274 participants
0.62  (0.26) 1.54  (0.26)
Month 12, n=286, 287 Number Analyzed 286 participants 287 participants
0.63  (0.28) 1.62  (0.27)
Month 18, n=287, 288 Number Analyzed 287 participants 288 participants
0.90  (0.33) 2.36  (0.33)
Month 24, n=287,290 Number Analyzed 287 participants 290 participants
0.93  (0.32) 2.27  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.26 to 1.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.33
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.30 to 1.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.35
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
0.63 to 2.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.54 to 2.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.41
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
5.Secondary Outcome
Title Number of Participants With Qmax Improvement From Baseline by LOCF Approach.
Hide Description 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.
Time Frame Baseline 6, 12, 18 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6, >= 3 mL/sec, n=270, 274 Number Analyzed 270 participants 274 participants
69
  25.6%
86
  31.4%
Month 6, >= 3 %, n=270, 274 Number Analyzed 270 participants 274 participants
70
  25.9%
86
  31.4%
Month 12, >= 3 mL/sec, n=286, 287 Number Analyzed 286 participants 287 participants
64
  22.4%
102
  35.5%
Month 12, >= 3 %, n=286, 287 Number Analyzed 286 participants 287 participants
73
  25.5%
107
  37.3%
Month 18, >= 3 mL/sec, n=287, 288 Number Analyzed 287 participants 288 participants
80
  27.9%
115
  39.9%
Month 18, >= 3 %, n= 287, 288 Number Analyzed 287 participants 288 participants
81
  28.2%
111
  38.5%
Month 24, >= 3 mL/sec, n=287, 290 Number Analyzed 287 participants 290 participants
77
  26.8%
121
  41.7%
Month 24, >= 30 %, n=287, 290 Number Analyzed 287 participants 290 participants
71
  24.7%
119
  41.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 6
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 6
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 12
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 12
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 18
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 18
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 24
Method Mantel Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 24
Method Mantel Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery
Hide Description AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Overall
15
   5.0%
4
   1.3%
Year 1 subset
8
   2.6%
2
   0.7%
Year 2 subset
7
   2.3%
2
   0.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
0.09 to 0.81
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With AUR
Hide Description AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Overall
13
   4.3%
2
   0.7%
Year 1 subset
8
   2.6%
2
   0.7%
Year 2 subset
5
   1.7%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.03 to 0.68
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With BPH-related Surgery
Hide Description BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Overall
3
   1.0%
2
   0.7%
Year 1 subset
0
   0.0%
0
   0.0%
Year 2 subset
3
   1.0%
2
   0.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.11 to 4.11
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach
Hide Description BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS 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 BHS.
Time Frame Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Deviation)
Unit of Measure: Scores on scale
Month 3, n=299, 296 Number Analyzed 299 participants 296 participants
-0.88  (0.08) -0.85  (0.08)
Month 6, n=300,298 Number Analyzed 300 participants 298 participants
-0.89  (0.08) -0.73  (0.08)
Month 9, n=300, 298 Number Analyzed 300 participants 298 participants
-1.08  (0.08) -0.95  (0.08)
Month 12, n=300, 298 Number Analyzed 300 participants 298 participants
-0.87  (0.08) -0.90  (0.08)
Month 15, n=300, 298 Number Analyzed 300 participants 298 participants
-0.93  (0.08) -1.02  (0.08)
Month 18, n=300, 298 Number Analyzed 300 participants 298 participants
-0.92  (0.08) -1.00  (0.08)
Month 21, n=300, 298 Number Analyzed 300 participants 298 participants
-1.08  (0.09) -1.02  (0.09)
Month 24, n=300, 298 Number Analyzed 300 participants 298 participants
-1.00  (0.08) -1.16  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.17 to 0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.04 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.07 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.23 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.30 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.30 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.16 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.37 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam
10.Secondary Outcome
Title Change From Baseline in BPH Impact Index (BII) by LOCF Approach
Hide Description 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.
Time Frame Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Error)
Unit of Measure: Scores on scale
Month 3, n=299, 296 Number Analyzed 299 participants 296 participants
-1.48  (0.14) -1.23  (0.14)
Month 6, n=300, 298 Number Analyzed 300 participants 298 participants
-1.28  (0.15) -1.08  (0.16)
Month 9, n=300, 298 Number Analyzed 300 participants 298 participants
-1.55  (0.15) -1.26  (0.16)
Month 12, n=300, 298 Number Analyzed 300 participants 298 participants
-1.39  (0.16) -1.24  (0.16)
Month 15, n=300, 298 Number Analyzed 300 participants 298 participants
-1.30  (0.16) -1.41  (0.16)
Month 18, n=300, 298 Number Analyzed 300 participants 298 participants
-1.16  (0.16) -1.28  (0.16)
Month 21, n=300, 298 Number Analyzed 300 participants 298 participants
-1.12  (0.17) -1.27  (0.17)
Month 24, n=300, 298 Number Analyzed 300 participants 298 participants
-1.02  (0.17) -1.48  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.11 to 0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.20 to 0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 6
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-0.10 to 0.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 9
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.25 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 12
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.51 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 15
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.52 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 18
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.56 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 21
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.88 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam for Month 24
11.Secondary Outcome
Title Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)
Hide Description 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.
Time Frame Baseline, 12 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Deviation)
Unit of Measure: Scores on scale
Month 12, n=291, 293 Number Analyzed 291 participants 293 participants
0.11  (0.21) -0.91  (0.20)
Month 24, n=291, 294 Number Analyzed 291 participants 294 participants
-0.11  (0.21) -0.82  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-1.54 to -0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.26
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.23 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam.
12.Secondary Outcome
Title Number of Hospitalization Days
Hide Description Duration of hospitalization days due to AUR or BPH-related surgery was recorded.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at specific time point were analyzed
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 5 3
Median (Full Range)
Unit of Measure: Days
10.0
(6 to 18)
9.0
(7 to 12)
13.Secondary Outcome
Title Number of Participants in a Hospital Ward
Hide Description 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
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at specific time point were analyzed
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
General ward
2
  66.7%
0
   0.0%
Recovery
0
   0.0%
1
 100.0%
Other
1
  33.3%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Hospital Admissions
Hide Description Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at specific time point were analyzed.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 11 3
Measure Type: Count of Participants
Unit of Measure: Participants
Out-patient
5
  45.5%
0
   0.0%
In-patient
6
  54.5%
3
 100.0%
15.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)
Hide Description 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
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Any Non-serious AE
203
  67.2%
208
  68.2%
Any SAE
52
  17.2%
49
  16.1%
16.Secondary Outcome
Title Change From Baseline in Serum Prostate Specific Antigen (PSA)
Hide Description 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.
Time Frame Baseline 6, 12 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
Month 6, n=292, 294 Number Analyzed 292 participants 294 participants
0.2  (0.09) -1.7  (0.08)
Month 12, n=293, 294 Number Analyzed 293 participants 294 participants
0.2  (0.08) -1.9  (0.08)
Month 24, n=293, 295 Number Analyzed 293 participants 295 participants
0.7  (0.16) -2.0  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.1 to -1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-2.3 to -1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24
Method General linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-3.1 to -2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments The adjusted mean difference was based on Dut+Tam minus Tam.
17.Secondary Outcome
Title Number of Participants With Vital Signs Exceeding Threshold Values
Hide Description 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).
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, < 80 mmHg
0
   0.0%
0
   0.0%
SBP, > 165 mmHg
10
   3.3%
13
   4.3%
SBP, either threshold
10
   3.3%
13
   4.3%
DBP, < 40 mmHg
0
   0.0%
0
   0.0%
DBP, > 105 mmHg
6
   2.0%
2
   0.7%
DBP, either threshold
6
   2.0%
2
   0.7%
Heart rate, < 40 bpm
0
   0.0%
0
   0.0%
Heart rate, > 100 bpm
11
   3.6%
14
   4.6%
Heart rate, either threshold
11
   3.6%
14
   4.6%
18.Secondary Outcome
Title Change From Baseline in Post Void Residual Volume
Hide Description 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.
Time Frame Baseline, 6, 12, 18 and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Mean (Standard Deviation)
Unit of Measure: mL
Month 6, n=288, 290 Number Analyzed 288 participants 290 participants
-4.8  (52.59) -3.0  (59.56)
Month 12, n=291, 292 Number Analyzed 291 participants 292 participants
1.5  (60.94) -1.4  (59.19)
Month 18, n=291, 292 Number Analyzed 291 participants 292 participants
-2.6  (55.67) -1.3  (63.98)
Month 24, n=291, 292 Number Analyzed 291 participants 292 participants
2.6  (64.71) -2.6  (62.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6
Method Van Elteren test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12
Method Van Elteren test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18
Method Van Elteren test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo + Tam 0.2mg, Dut 0.5 mg + Tam 0.2 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24
Method Van Elteren test
Comments [Not Specified]
19.Secondary Outcome
Title Number of Participants With Threshold Hematology Value.
Hide Description 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.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Hgb, <0.75 X LLN, n=287, 291 Number Analyzed 287 participants 291 participants
0
   0.0%
0
   0.0%
Platelet count, <0.75 X LLN, n=284, 283 Number Analyzed 284 participants 283 participants
6
   2.1%
1
   0.4%
Platelet count, >1.50 X ULN, n=285, 285 Number Analyzed 285 participants 285 participants
0
   0.0%
0
   0.0%
RBC, <0.50 X LLN, n=287, 291 Number Analyzed 287 participants 291 participants
0
   0.0%
0
   0.0%
WBC, <0.50 X LLN, n=287, 291 Number Analyzed 287 participants 291 participants
0
   0.0%
0
   0.0%
WBC, >3.00 X ULN, n=287, 291 Number Analyzed 287 participants 291 participants
0
   0.0%
0
   0.0%
20.Secondary Outcome
Title Number of Participants With Threshold Clinical Chemistry Value.
Hide Description 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.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
albumin, <0.90 X LLN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
albumin, >1.20 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
ALT, >3.00 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
ALP, > 1.50 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
AST, >3.00 X ULN, n=288, 292 Number Analyzed 288 participants 292 participants
0
   0.0%
1
   0.3%
creatinine, <0.50 X LLN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
creatinine, >3.00 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
glucose, <0.70 X LLN, n=288, 292 Number Analyzed 288 participants 292 participants
0
   0.0%
0
   0.0%
glucose, >1.75 X ULN, n=280, 285 Number Analyzed 280 participants 285 participants
13
   4.6%
13
   4.6%
potassium, <0.75 X LLN, n=288, 292 Number Analyzed 288 participants 292 participants
0
   0.0%
0
   0.0%
potassium, >1.40 X ULN, n=288, 292 Number Analyzed 288 participants 292 participants
0
   0.0%
0
   0.0%
sodium, <0.90 X LLN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
sodium, >1.15 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
total bilirubin, >2.50 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
total protein, <0.80 X LLN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
total protein, >1.15 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
Urea/BUN, <0.50 X LLN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
Urea/BUN, >2.00 X ULN, n=289, 292 Number Analyzed 289 participants 292 participants
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Digital Rectal Examination (DRE)
Hide Description 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.
Time Frame 6, 12, 18 , 24 months and final assessment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6, n=287, 285 Number Analyzed 287 participants 285 participants
11
   3.8%
9
   3.2%
Month 12, n=279, 272 Number Analyzed 279 participants 272 participants
10
   3.6%
11
   4.0%
Month 18, n=267, 258 Number Analyzed 267 participants 258 participants
6
   2.2%
12
   4.7%
Month 24, n=261, 252 Number Analyzed 261 participants 252 participants
10
   3.8%
13
   5.2%
Final Assessment, n=296, 295 Number Analyzed 296 participants 295 participants
10
   3.4%
15
   5.1%
22.Secondary Outcome
Title Number of Participants With Clinically Significant Qualitative Breast Examination
Hide Description 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.
Time Frame 6, 12, 18 , 24 months and final assessment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Palpable breast tissue, Month 6, n=289, 284 Number Analyzed 289 participants 284 participants
0
   0.0%
0
   0.0%
Nipple tenderness,Month 6, n=289, 284 Number Analyzed 289 participants 284 participants
0
   0.0%
0
   0.0%
Palpable breast tissue, Month 12, n=279, 273 Number Analyzed 279 participants 273 participants
1
   0.4%
2
   0.7%
Nipple tenderness,Month 12, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
1
   0.4%
Palpable breast tissue, Month 18, n=267, 258 Number Analyzed 267 participants 258 participants
1
   0.4%
0
   0.0%
Nipple tenderness,Month 18, n=267, 258 Number Analyzed 267 participants 258 participants
0
   0.0%
0
   0.0%
Palpable breast tissue, Month 24, n=262, 252 Number Analyzed 262 participants 252 participants
0
   0.0%
0
   0.0%
Nipple tenderness, Month 24, n=262, 252 Number Analyzed 262 participants 252 participants
0
   0.0%
0
   0.0%
Palpable breast tissue,final assessment, n=296,296 Number Analyzed 296 participants 296 participants
0
   0.0%
0
   0.0%
Nipple tenderness,final assessment, n=296, 296 Number Analyzed 296 participants 296 participants
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior
Hide Description 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.
Time Frame 6, 12, 18 , 24 months and final assessment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description:
Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.
Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Number of Participants Analyzed 302 305
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6, Suicidal ideation, Q1, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal ideation, Q2, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal behavior, Q6, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal behavior, Q7, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal behavior, Q8, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal behavior, Q9, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 6, Suicidal behavior, Q10, n=289, 285 Number Analyzed 289 participants 285 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal ideation, Q1, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal ideation, Q2, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q6, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q7, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q8, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q9, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q10, n=279, 273 Number Analyzed 279 participants 273 participants
0
   0.0%
0
   0.0%
Month 24, Suicidal ideation, Q1, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
1
   0.4%
Month 24, Suicidal ideation, Q2, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q6, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q7, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q8, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q9, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Month 12, Suicidal behavior, Q10, n=261, 251 Number Analyzed 261 participants 251 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal ideation,Q1, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
1
   0.4%
Final assessment, Suicidal ideation,Q2, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal behavior,Q6, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal behavior,Q7, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal behavior,Q8, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal behavior,Q9, n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Final assessment, Suicidal behavior,Q10,n=288, 285 Number Analyzed 288 participants 285 participants
0
   0.0%
0
   0.0%
Time Frame Up to 24 months
Adverse Event Reporting Description Participants who withdrew for sexual function events were followed up for 6 months after treatment discontinuation.
 
Arm/Group Title Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Hide Arm/Group Description Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks. Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
All-Cause Mortality
Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/302 (0.33%)      2/305 (0.66%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Tam 0.2mg Dut 0.5 mg + Tam 0.2 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/302 (17.22%)      49/305 (16.07%)    
Cardiac disorders     
Arteriosclerosis coronary artery  1  2/302 (0.66%)  3 3/305 (0.98%)  3
Acute myocardial infarction  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Angina pectoris  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Atrial fibrillation  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Coronary artery disease  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Hypertensive heart disease  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Ear and labyrinth disorders     
Vertigo positional  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Endocrine disorders     
Hyperthyroidism  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Thyroid mass  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Eye disorders     
Cataract  1  2/302 (0.66%)  2 0/305 (0.00%)  0
Macular hole  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Dacryostenosis acquired  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Gastrointestinal disorders     
Inguinal hernia  1  5/302 (1.66%)  5 2/305 (0.66%)  2
Large intestine polyp  1  7/302 (2.32%)  7 0/305 (0.00%)  0
Haemorrhoids  1  2/302 (0.66%)  2 0/305 (0.00%)  0
Enteritis  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Gastric ulcer  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Oesophageal achalasia  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Pancreatic disorder  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Functional gastrointestinal disorder  1  1/302 (0.33%)  1 0/305 (0.00%)  0
General disorders     
Hernia  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Accidental death  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Implant site inflammation  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Hepatobiliary disorders     
Bile duct stone  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Cholecystitis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Cholecystitis acute  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Hepatitis toxic  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Infections and infestations     
Bronchitis  1  2/302 (0.66%)  2 0/305 (0.00%)  0
Appendicitis  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Cellulitis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Dacryocystitis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Sinusitis  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Urinary tract infection  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Pneumonia bacterial  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Lung infection  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Bacterial prostatitis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/302 (0.00%)  0 2/305 (0.66%)  2
Femur fracture  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Hand fracture  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Ligament sprain  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Subdural haematoma  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Contusion  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Lower limb fracture  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  2/302 (0.66%)  2 0/305 (0.00%)  0
Intervertebral disc protrusion  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Arthralgia  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Osteoarthritis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Lung neoplasm malignant  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Prostate cancer  1  2/302 (0.66%)  2 0/305 (0.00%)  0
Adenocarcinoma of colon  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Benign oesophageal neoplasm  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Colon cancer  1  1/302 (0.33%)  3 0/305 (0.00%)  0
Liposarcoma  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Lung adenocarcinoma  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Lymphoma  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Polycythaemia vera  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Rectal cancer  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Squamous cell carcinoma of lung  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Rectal adenoma  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Hepatic cancer  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Large intestine benign neoplasm  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Pancreatic carcinoma  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Nervous system disorders     
Syncope  1  1/302 (0.33%)  1 2/305 (0.66%)  2
Carotid artery stenosis  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Cerebral haemorrhage  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Cerebral infarction  1  2/302 (0.66%)  3 0/305 (0.00%)  0
Lacunar infarction  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Cerebrovascular insufficiency  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Brain stem infarction  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Cerebral artery embolism  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Headache  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Trigeminal neuralgia  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Ulnar nerve palsy  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Psychiatric disorders     
Mental status changes  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Renal and urinary disorders     
Calculus bladder  1  0/302 (0.00%)  0 2/305 (0.66%)  2
Albuminuria  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Hydronephrosis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Nephrolithiasis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Nephrotic syndrome  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Renal artery stenosis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Urinary retention  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Chronic kidney disease  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Urinary tract inflammation  1  1/302 (0.33%)  2 0/305 (0.00%)  0
Bladder outlet obstruction  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/302 (0.33%)  1 1/305 (0.33%)  1
Prostatitis  1  1/302 (0.33%)  1 0/305 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  0/302 (0.00%)  0 1/305 (0.33%)  1
Eczema  1  0/302 (0.00%)  0