Trial Outcomes & Findings for Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH) (NCT NCT01460342)
NCT ID: NCT01460342
Last Updated: 2013-09-25
Results Overview
The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
610 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2013-09-25
Participant Flow
The study consisted of 3 periods: a screening/wash-out period (pre-randomization, 1 day up to 4 weeks), a placebo lead-in period (pre-randomization, 4 weeks, participant-blinded), and a double-blind treatment period (post-randomization, 12 weeks).
Participant milestones
| Measure |
Placebo
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
306
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
304
|
306
|
|
Overall Study
COMPLETED
|
293
|
292
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)
Baseline characteristics by cohort
| Measure |
Placebo
n=304 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=306 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
Total
n=610 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Age, Customized
<65 years
|
201 participants
n=5 Participants
|
198 participants
n=7 Participants
|
399 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
103 participants
n=5 Participants
|
108 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
610 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
304 participants
n=5 Participants
|
306 participants
n=7 Participants
|
610 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
222 participants
n=5 Participants
|
227 participants
n=7 Participants
|
449 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
82 participants
n=5 Participants
|
79 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.1 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 2.9 • n=5 Participants
|
24.0 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.0 • n=7 Participants
|
24.0 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Current Tobacco Use
Yes
|
55 participants
n=5 Participants
|
57 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Current Tobacco Use
No
|
249 participants
n=5 Participants
|
249 participants
n=7 Participants
|
498 participants
n=5 Participants
|
|
Alcohol Use
Yes
|
196 participants
n=5 Participants
|
206 participants
n=7 Participants
|
402 participants
n=5 Participants
|
|
Alcohol Use
No
|
108 participants
n=5 Participants
|
100 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Benign Prostatic Hyperplasia (BPH) Severity
Mild (IPSS Total Score 0 to 7)
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Benign Prostatic Hyperplasia (BPH) Severity
Moderate (IPSS Total Score 8 to 19)
|
167 participants
n=5 Participants
|
166 participants
n=7 Participants
|
333 participants
n=5 Participants
|
|
Benign Prostatic Hyperplasia (BPH) Severity
Severe (IPSS Total Score >=20)
|
132 participants
n=5 Participants
|
134 participants
n=7 Participants
|
266 participants
n=5 Participants
|
|
Duration of BPH
|
4.0 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
4.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
4.0 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Patient Global Impression of Severity (PGI-S) Scale
Normal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Patient Global Impression of Severity (PGI-S) Scale
Mild
|
67 participants
n=5 Participants
|
64 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Patient Global Impression of Severity (PGI-S) Scale
Moderate
|
187 participants
n=5 Participants
|
195 participants
n=7 Participants
|
382 participants
n=5 Participants
|
|
Patient Global Impression of Severity (PGI-S) Scale
Severe
|
50 participants
n=5 Participants
|
47 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scale
Normal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scale
Mild
|
33 participants
n=5 Participants
|
41 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scale
Moderate
|
218 participants
n=5 Participants
|
211 participants
n=7 Participants
|
429 participants
n=5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scale
Severe
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Previous Alpha-Blocker Therapy
Yes
|
43 participants
n=5 Participants
|
39 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Previous Alpha-Blocker Therapy
No
|
261 participants
n=5 Participants
|
267 participants
n=7 Participants
|
528 participants
n=5 Participants
|
|
Previous Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) Therapy
Yes
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Previous Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) Therapy
No
|
283 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
567 Participants
n=5 Participants
|
|
Postvoid Residual Volume (PVR)
|
32.7 milliliters (mL)
STANDARD_DEVIATION 50.0 • n=5 Participants
|
26.9 milliliters (mL)
STANDARD_DEVIATION 37.7 • n=7 Participants
|
29.8 milliliters (mL)
STANDARD_DEVIATION 44.3 • n=5 Participants
|
|
Prostate Volume
|
31.6 mL
STANDARD_DEVIATION 9.5 • n=5 Participants
|
30.7 mL
STANDARD_DEVIATION 8.5 • n=7 Participants
|
31.1 mL
STANDARD_DEVIATION 9.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks
|
-4.5 units on a scale
Standard Error 0.4
|
-6.0 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)
Change at Week 4
|
-2.8 units on a scale
Standard Error 0.3
|
-4.0 units on a scale
Standard Error 0.4
|
|
Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)
Change at Week 8
|
-4.0 units on a scale
Standard Error 0.4
|
-5.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The IPSS Storage (Irritative) Subscore was the sum of Questions 2, 4, and 7 in the IPSS questionnaire. Each question was scored from 0 (no irritative symptoms) to 5 (frequent irritative symptoms) for an IPSS Storage (Irritative) Subscore that ranged from 0 to 15; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore
Change at 4 Weeks
|
-0.9 units on a scale
Standard Error 0.1
|
-1.2 units on a scale
Standard Error 0.2
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore
Change at 8 Weeks
|
-1.3 units on a scale
Standard Error 0.2
|
-1.7 units on a scale
Standard Error 0.2
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore
Change at 12 Weeks
|
-1.4 units on a scale
Standard Error 0.2
|
-2.0 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The IPSS Voiding (Obstructive) Subscore was the sum of Questions 1, 3, 5, and 6 in the IPSS questionnaire. Each question was scored from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms) for an IPSS Voiding (Obstructive) Subscore that ranged from 0 to 20; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Change at Week 8
|
-2.6 units on a scale
Standard Error 0.3
|
-3.4 units on a scale
Standard Error 0.3
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Change at Week 4
|
-1.8 units on a scale
Standard Error 0.2
|
-2.8 units on a scale
Standard Error 0.2
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore
Change at Week 12
|
-3.1 units on a scale
Standard Error 0.3
|
-4.0 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The IPSS QoL Index assessed the participant's response to the following question, "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Response options were 0 (Delighted), 1 (Pleased), 2 (Mostly satisfied), 3 (Mixed, about equally satisfied and dissatisfied), 4 (Mostly dissatisfied), 5 (Unhappy), and 6 (Terrible), for a QoL Index Score that ranged from 0 to 6. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Change at Week 4
|
-0.5 units on a scale
Standard Error 0.1
|
-0.6 units on a scale
Standard Error 0.1
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Change at Week 8
|
-0.7 units on a scale
Standard Error 0.1
|
-0.8 units on a scale
Standard Error 0.1
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index
Change at Week 12
|
-0.9 units on a scale
Standard Error 0.1
|
-1.1 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Randomized participants who received at least 1 dose of study drug.
The PGI-I scale measured the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).
Outcome measures
| Measure |
Placebo
n=304 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=306 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
Much Better
|
55 participants
|
79 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
A Little Better
|
138 participants
|
148 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
No Change
|
90 participants
|
55 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
A Little Worse
|
7 participants
|
2 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
Very Much Better
|
9 participants
|
18 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
Much Worse
|
0 participants
|
0 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
Very Much Worse
|
2 participants
|
0 participants
|
|
Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks
Missing
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Randomized participants who received at least 1 dose of study drug.
The CGI-I measured the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).
Outcome measures
| Measure |
Placebo
n=304 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=306 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Missing
|
3 participants
|
4 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Very Much Improved
|
10 participants
|
14 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Much Improved
|
74 participants
|
103 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Minimally Improved
|
115 participants
|
125 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
No Change
|
93 participants
|
59 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Minimally Worse
|
8 participants
|
1 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Much Worse
|
0 participants
|
0 participants
|
|
Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks
Very Much Worse
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 2 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.
The mIPSS Total Score was the sum of Questions 1 through 7 in the mIPSS questionnaire, which was a modified version of the IPSS questionnaire. Questions about the participant's urination experiences and prostate symptoms in the IPSS questionnaire were modified to obtain responses based on time since the last visit rather than during the last month. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an mIPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the analysis of covariance (ANCOVA) model with treatment, prior alpha-blocker use (yes/no), and country (Japan/Korea) as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.
Outcome measures
| Measure |
Placebo
n=301 Participants
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=305 Participants
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks
|
-2.1 units on a scale
Standard Error 0.3
|
-2.7 units on a scale
Standard Error 0.3
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
Tadalafil
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=304 participants at risk
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=306 participants at risk
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=304 participants at risk
Placebo: 2 tablets \[identical to 2.5-milligram (mg) tadalafil tablets\] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
|
Tadalafil
n=306 participants at risk
Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period \[2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily\].
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/304
|
0.65%
2/306 • Number of events 2
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Ear and labyrinth disorders
Vertigo
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Eye disorders
Asthenopia
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Eye disorders
Astigmatism
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.33%
1/304 • Number of events 1
|
0.65%
2/306 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Constipation
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/304 • Number of events 1
|
1.6%
5/306 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
2/304 • Number of events 2
|
3.9%
12/306 • Number of events 12
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/304
|
0.65%
2/306 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Gastrointestinal disorders
Lip dry
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Periodontal disease
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Gastrointestinal disorders
Periodontitis
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Gastrointestinal disorders
Stomatitis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/304
|
0.65%
2/306 • Number of events 2
|
|
General disorders
Granuloma
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
General disorders
Malaise
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
General disorders
Therapeutic response unexpected
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.99%
3/304 • Number of events 3
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.33%
1/304 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Infections and infestations
Herpes simplex
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Infections and infestations
Herpes zoster
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Infections and infestations
Influenza
|
0.33%
1/304 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
10/304 • Number of events 11
|
4.2%
13/306 • Number of events 14
|
|
Infections and infestations
Otitis media
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/304
|
0.98%
3/306 • Number of events 3
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Tracheitis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
5/304 • Number of events 5
|
0.65%
2/306 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
4/304 • Number of events 4
|
0.00%
0/306
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
6/304 • Number of events 6
|
0.33%
1/306 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Investigations
Blood chloride decreased
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
2.3%
7/304 • Number of events 7
|
2.3%
7/306 • Number of events 7
|
|
Investigations
Blood sodium decreased
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Investigations
Blood urine
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Investigations
Creatinine renal clearance decreased
|
0.33%
1/304 • Number of events 1
|
1.3%
4/306 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.99%
3/304 • Number of events 3
|
0.33%
1/306 • Number of events 1
|
|
Investigations
Glucose urine present
|
0.00%
0/304
|
0.65%
2/306 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.33%
1/304 • Number of events 1
|
0.65%
2/306 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
3/304 • Number of events 3
|
1.3%
4/306 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.33%
1/304 • Number of events 1
|
0.33%
1/306 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.33%
1/304 • Number of events 1
|
0.98%
3/306 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/304 • Number of events 1
|
0.65%
2/306 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/304
|
0.65%
2/306 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.0%
6/304 • Number of events 6
|
2.9%
9/306 • Number of events 9
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Psychiatric disorders
Anxiety disorder
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Renal and urinary disorders
Haematuria
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Renal and urinary disorders
Proteinuria
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Renal and urinary disorders
Renal impairment
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Renal and urinary disorders
Urinary retention
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.66%
2/304 • Number of events 2
|
1.3%
4/306 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/304
|
0.33%
1/306 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Surgical and medical procedures
Electrocauterisation
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Surgical and medical procedures
Rectal polypectomy
|
0.33%
1/304 • Number of events 1
|
0.00%
0/306
|
|
Surgical and medical procedures
Tooth extraction
|
0.66%
2/304 • Number of events 2
|
0.00%
0/306
|
|
Vascular disorders
Hot flush
|
0.33%
1/304 • Number of events 1
|
0.65%
2/306 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60