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Trial record 74 of 117 for:    DUTASTERIDE

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement (CONDUCT)

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ClinicalTrials.gov Identifier: NCT01294592
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : June 16, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostatic Hyperplasia
Interventions Drug: Dutasteride plus tamsulosin
Drug: tamsulosin
Enrollment 742
Recruitment Details  
Pre-assignment Details Treatment-naïve men with symptomatic benign prostatic hyperplasia (BPH) meeting eligibility criteria were enrolled and were randomized in a 1:1 ratio to receive dutasteride plus tamsulosin once daily plus lifestyle advice or watchful waiting plus lifestyle advice.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months. All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Period Title: Overall Study
Started 369 373
Completed 292 300
Not Completed 77 73
Reason Not Completed
Adverse Event             28             13
Lack of Efficacy             7             5
Protocol Violation             1             7
Lost to Follow-up             7             9
Physician Decision             6             11
Withdrawal by Subject             28             28
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Total
Hide Arm/Group Description Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months. All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No). Total of all reporting groups
Overall Number of Baseline Participants 369 373 742
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 369 participants 373 participants 742 participants
66.3  (7.78) 66.2  (7.34) 66.2  (7.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 373 participants 742 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
369
 100.0%
373
 100.0%
742
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 369 participants 373 participants 742 participants
White - White/Caucasian/European Heritage 357 363 720
White - Arabic/North African Heritage 4 2 6
African American/African Heritage 0 2 2
Mixed Race 0 1 1
Missing 8 5 13
1.Primary Outcome
Title Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach
Hide Description The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 368
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=358, 367 -3.2  (0.21) -0.9  (0.20)
Month 3, n=359, 368 -4.5  (0.22) -2.4  (0.22)
Month 6, n=359, 368 -4.6  (0.23) -3.2  (0.22)
Month 9, n=359, 368 -5.1  (0.22) -3.6  (0.22)
Month 12, n=359, 368 -5.2  (0.23) -3.6  (0.23)
Month 15, n=359, 368 -5.2  (0.25) -3.6  (0.24)
Month 18, n=359, 368 -5.1  (0.25) -3.3  (0.25)
Month 21, n=359, 368 -5.5  (0.25) -3.6  (0.24)
Month 24, n=359, 368 -5.4  (0.25) -3.6  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 1
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-2.8 to -1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 3
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-2.7 to -1.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 6
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.1 to -0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 9
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.2 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.31
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 12
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.2 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.32
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 15
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.3 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 18
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.4 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.35
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 21
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.5 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Dutasteride Plus Tamsulosin, Watchful Waiting All: Escalated Yes and No
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Month 24
Method t-test, 2 sided
Comments Values are based on t-tests from the general linear model
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.5 to -1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.
2.Secondary Outcome
Title Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Hide Description Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 368
Measure Type: Number
Unit of Measure: Participants
Month 1, >=2 points, n=358, 367 225 149
Month 1, >=3 points, n=358, 367 182 90
Month 1, >=25 percent, n=358, 367 161 76
Month 3, >=2 points, n=359, 368 277 221
Month 3, >=3 points, n=359, 368 233 172
Month 3, >=25 percent, n= 359, 368 218 150
Month 6, >=2 points, n=359, 368 277 250
Month 6, >=3 points, n=359, 368 245 208
Month 6, >=25 percent, n=359, 368 229 189
Month 9, >=2 points, n=359, 368 286 276
Month 9, >=3 points, n=359, 368 257 222
Month 9, >=25 percent, n=359, 368 247 207
Month 12, >=2 points, n=359, 368 291 273
Month 12, >=3 points, n=359, 368 261 229
Month 12, >=25 percent, n= 359, 368 249 214
Month 15, >=2 points, n=359, 368 289 275
Month 15, >=3 points, n=359, 368 259 243
Month 15, >=25 percent, n=359, 368 245 231
Month 18, >=2 points, n=359, 368 288 268
Month 18, >=3 points, n=359, 368 262 229
Month 18, >=25 percent, 359, 368 245 212
Month 21, >=2 points, n=359, 368 292 274
Month 21, >=3 points, n=359, 368 267 237
Month 21, >=25 percent, n= 359, 368 253 224
Month 24, >=2 points, n=359, 368 295 279
Month 24, >=3points, n=359, 368 277 234
Month 24, >=25 percent, n= 359, 368 261 221
3.Secondary Outcome
Title Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Hide Description The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 368
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=357, 366 -1.3  (0.11) -0.4  (0.11)
Month 3, n=359, 368 -1.8  (0.11) -1.0  (0.11)
Month 6, n=359, 368 -1.9  (0.11) -1.3  (0.11)
Month 9, n=359, 368 -2.1  (0.11) -1.5  (0.11)
Month 12, n=359, 368 -2.1  (0.12) -1.5  (0.12)
Month 15, n=359, 368 -2.2  (0.12) -1.5  (0.12)
Month 18, n=359, 368 -2.2  (0.12) -1.4  (0.12)
Month 21, n=359, 368 -2.4  (0.12) -1.6  (0.12)
Month 24, n=359, 368 -2.4  (0.12) -1.6  (0.12)
4.Secondary Outcome
Title Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Hide Description Each participant was asked the following question “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”. This response was rated from 0 (“delighted”) to 6 (“terrible”). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 368
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=358, 367 -0.8  (0.06) -0.3  (0.05)
Month 3, n=359, 368 -1.1  (0.06) -0.7  (0.06)
Month 6, n=359, 368 -1.2  (0.06) -0.9  (0.06)
Month 9, n=359, 368 -1.3  (0.06) -1.0  (0.06)
Month 12, n=359, 368 -1.3  (0.06) -1.1  (0.06)
Month 15, n=359, 368 -1.4  (0.06) -1.1  (0.06)
Month 18, n=359, 368 -1.4  (0.06) -1.1  (0.06)
Month 21, n=359, 368 -1.5  (0.06) -1.1  (0.06)
Month 24, n=359, 368 -1.5  (0.06) -1.1  (0.06)
5.Secondary Outcome
Title Number of Events of Clinical Progression (CP) of BPH
Hide Description The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants at risk for CP at the specified visit were analyzed.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 369 373
Measure Type: Number
Unit of Measure: Events
Year 1, n=369, 373 48 94
Year 2, n=276, 251 17 14
6.Secondary Outcome
Title Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH
Hide Description CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components ("Tied for first component"), and the number of participants with multiple first-occurring components were summarized by treatment group.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 369 373
Measure Type: Number
Unit of Measure: Participants
Participants with CP of BPH, n=369, 373 65 108
BPH symptom progression, n=65, 108 59 97
BPH-related AUR, n=65, 108 2 4
BPH-related incontinence, n=65, 108 4 3
Recurrent BPH-related UTI, n=65, 108 0 4
BPH-related renal insufficiency, n=65, 108 0 0
Tied for first component, n=65, 108 0 0
Multiple components (2 components), n=65, 108 4 9
Multiple components (3 components), n=65, 108 0 1
Multiple components (>=4 components), n=65, 108 0 1
7.Secondary Outcome
Title Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries
Hide Description BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 369 373
Measure Type: Number
Unit of Measure: Participants
Participants with any BPH-related surgery 6 3
Participants with cystoscopy 5 1
Participants with TURP 2 1
Participants with prostatectomy 0 1
Participants with 2 surgeries 1 0
Participants with >=3 surgeries 0 0
8.Secondary Outcome
Title Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Hide Description The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: "Overall, how satisfied are you with the treatment and its effect on your urinary problems?" There were seven possible responses, including: "very satisfied," "satisfied," "somewhat satisfied," neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied." Response categories were created by grouping together "very satisfied," "satisfied," and "somewhat satisfied" responses into the category of "Any Satisfaction (AS)," and separately grouping "neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied" responses into the category of "Neutral or Any Dissatisfaction (N/AD)." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 364
Measure Type: Number
Unit of Measure: Participants
Baseline, Any Satisfaction, n=315, 328 119 122
Baseline, Neutral/Any Dissatisfaction, n=315, 328 196 206
Month 1, Any Satisfaction, n=358, 349 272 209
Month 1, Neutral/Any Dissatisfaction, n=358, 349 86 140
Month 3, Any Satisfaction, n= 359, 359 300 265
Month 3, Neutral/Any Dissatisfaction, n=359, 359 59 94
Month 6, Any Satisfaction, n=359, 361 301 285
Month 6, Neutral /Any Dissatisfaction, n=359, 361 58 76
Month 9, Any Satisfaction, n=359, 361 304 293
Month 9, Neutral/Any Dissatisfaction, n= 359, 361 55 68
Month 12, Any Satisfaction, n=359, 363 311 305
Month 12, Neutral/Any Dissatisfaction, n=359, 363 48 58
Month 15, Any Satisfaction, n=359, 364 311 299
Month 15, Neutral/Any Dissatisfaction, n=359, 364 48 65
Month 18, Any Satisfaction, n=359, 364 305 298
Month 18, Neutral/Any Dissatisfaction, n=359, 364 54 66
Month 21, Any Satisfaction, n=359, 364 310 300
Month 21, Neutral/Any Dissatisfaction, n=359, 364 49 64
Month 24, Any Satisfaction, n=359, 364 312 312
Month 24, Neutral/Any Dissatisfaction, n=359, 364 47 52
9.Secondary Outcome
Title Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Hide Description The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: "Would you ask your doctor for the treatment you received in this study?" There were three possible responses, including: "Yes," "No," and "Not sure." Response categories included "Yes" and "No or Not Sure," created by grouping together "No" and "Not sure." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time Frame Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
Overall Number of Participants Analyzed 359 364
Measure Type: Number
Unit of Measure: Participants
Baseline, Yes, n=315, 328 109 103
Baseline, No or Not Sure, n=315, 328 206 225
Month 1, Yes, n=358, 347 224 166
Month 1, No or Not Sure, n=358, 347 134 181
Month 3, Yes, n=359, 357 232 207
Month 3, No or Not Sure, n=359, 357 127 150
Month 6, Yes, n=359, 360 232 227
Month 6, No or Not Sure, n=359, 360 127 133
Month 9, Yes, n=359, 361 238 231
Month 9, No or Not Sure, n=359, 361 121 130
Month 12, Yes, n=359, 363 240 229
Month 12, No or Not Sure, n=359, 363 119 134
Month 15, Yes, n=359, 364 246 239
Month 15, No or Not Sure, n=359, 364 113 125
Month 18, Yes, n=359, 364 235 236
Month 18, No or Not Sure, n=359, 364 124 128
Month 21, Yes, n=359, 364 249 234
Month 21, No or Not Sure, n=359, 364 110 130
Month 24, Yes, n=359, 364 243 236
Month 24, No or Not Sure, n=359, 364 116 128
10.Secondary Outcome
Title Exposure to Study Drug
Hide Description Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting Escalated=Yes
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Overall Number of Participants Analyzed 368 229
Mean (Standard Deviation)
Unit of Measure: days
639.8  (215.49) 566.3  (195.13)
11.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization
Hide Description A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
Hide Arm/Group Description:
Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
Overall Number of Participants Analyzed 369 373 229
Measure Type: Number
Unit of Measure: Participants
Any AE 190 119 95
Any SAE 38 25 19
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years).
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the ITT Population.
 
Arm/Group Title Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
Hide Arm/Group Description Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months. All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
All-Cause Mortality
Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/369 (10.30%)   25/373 (6.70%)   19/229 (8.30%) 
Blood and lymphatic system disorders       
Anaemia  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Anaemia megaloblastic  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Lymphadenopathy  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Cardiac disorders       
Atrial fibrillation  1  4/369 (1.08%)  2/373 (0.54%)  2/229 (0.87%) 
Cardiac failure  1  1/369 (0.27%)  1/373 (0.27%)  1/229 (0.44%) 
Acute myocardial infarction  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Aortic valve stenosis  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Atrioventricular block  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Cardiomyopathy  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Coronary artery disease  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Supraventricular tachycardia  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Tachycardia  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Tachyarrhythmia  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Heart valve incompetence  1  0/369 (0.00%)  1/373 (0.27%)  0/229 (0.00%) 
Endocrine disorders       
Goitre  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Eye disorders       
Ulcerative keratitis  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Gastrointestinal disorders       
Inguinal hernia  1  2/369 (0.54%)  1/373 (0.27%)  0/229 (0.00%) 
Abdominal pain  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Anal fistula  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Gastritis  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Haemorrhoids  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Ileus  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Pancreatitis  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Pancreatitis acute  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Pancreatitis necrotising  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
General disorders       
Chest pain  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Death  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Pyrexia  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Infections and infestations       
Respiratory tract infection  1  1/369 (0.27%)  2/373 (0.54%)  2/229 (0.87%) 
Cellulitis  1  2/369 (0.54%)  0/373 (0.00%)  0/229 (0.00%) 
Diverticulitis  1  0/369 (0.00%)  2/373 (0.54%)  1/229 (0.44%) 
Erysipelas  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Pilonidal cyst  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Pneumonia  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Urinary tract infection  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Infective exacerbation of chronic obstructive airways  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Infected cyst  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Abdominal sepsis  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Hip fracture  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Contusion  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Post procedural haemorrhage  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Wound  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Lower limb fracture  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Post procedural haematuria  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Craniocerebral injury  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Investigations       
Transaminases increased  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Metabolism and nutrition disorders       
Metabolic acidosis  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Osteoarthritis  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Polymyalgia rheumatica  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/369 (0.00%)  2/373 (0.54%)  2/229 (0.87%) 
Prostate cancer  1  0/369 (0.00%)  2/373 (0.54%)  1/229 (0.44%) 
B-cell lymphoma  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Bladder neoplasm  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Bronchial carcinoma  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Metastases to bone  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Metastases to liver  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Hepatocellular carcinoma  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Myxoid liposarcoma  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Nervous system disorders       
Presyncope  1  2/369 (0.54%)  0/373 (0.00%)  0/229 (0.00%) 
Syncope  1  1/369 (0.27%)  1/373 (0.27%)  0/229 (0.00%) 
Transient ischaemic attack  1  1/369 (0.27%)  1/373 (0.27%)  1/229 (0.44%) 
Cerebellar infarction  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Cerebral infarction  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Dizziness  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Sciatica  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Renal and urinary disorders       
Calculus bladder  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Renal failure acute  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Urinary retention  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Renal impairment  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Reproductive system and breast disorders       
Prostatitis  1  1/369 (0.27%)  2/373 (0.54%)  1/229 (0.44%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/369 (0.27%)  1/373 (0.27%)  1/229 (0.44%) 
Dyspnoea  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Lung disorder  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Respiratory acidosis  1  0/369 (0.00%)  1/373 (0.27%)  1/229 (0.44%) 
Respiratory failure  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Vascular disorders       
Hypertension  1  1/369 (0.27%)  0/373 (0.00%)  0/229 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride Plus Tamsulosin Watchful Waiting All: Escalated Yes and No Watchful Waiting Escalated=Yes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/369 (11.65%)   13/373 (3.49%)   12/229 (5.24%) 
Reproductive system and breast disorders       
Erectile dysfunction  1  31/369 (8.40%)  4/373 (1.07%)  3/229 (1.31%) 
Retrograde ejaculation  1  19/369 (5.15%)  10/373 (2.68%)  10/229 (4.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01294592     History of Changes
Other Study ID Numbers: 114615
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: May 15, 2014
Results First Posted: June 16, 2014
Last Update Posted: August 20, 2018