Trial · NCT01460342
Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)
NCT01460342, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH). Trials, record NCT01460342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01460342
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)
- NCT number
- NCT01460342
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 610 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo
- First posted
- 2011-10-26
- Last updated
- 2013-09-25
- Results first posted
- 2013-09-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks | Baseline, 12 weeks | 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. |
| Secondary | Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Baseline, 4 weeks, 8 weeks | 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. |
| Secondary | Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Secondary | Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Secondary | Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Secondary | Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks | 12 Weeks | 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). |
| Secondary | Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks | 12 Weeks | 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). |
| Secondary | Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks | Baseline, 2 weeks | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks | Baseline, 12 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Baseline, 4 weeks, 8 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Baseline, 4 weeks, 8 weeks, 12 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Baseline, 4 weeks, 8 weeks, 12 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Baseline, 4 weeks, 8 weeks, 12 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks | 12 Weeks | Randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks | 12 Weeks | Randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks | Baseline, 2 weeks | Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks | Placebo | -4.5 | Standard Error 0.4 | units on a scale | |
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks | Tadalafil | -6.0 | Standard Error 0.4 | units on a scale | |
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Placebo | Change at Week 4 | -2.8 | Standard Error 0.3 | units on a scale |
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Tadalafil | Change at Week 4 | -4.0 | Standard Error 0.4 | units on a scale |
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Placebo | Change at Week 8 | -4.0 | Standard Error 0.4 | units on a scale |
| Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) | Tadalafil | Change at Week 8 | -5.2 | Standard Error 0.4 | units on a scale |
| Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Placebo | Change at 4 Weeks | -0.9 | Standard Error 0.1 | units on a scale |
| Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Tadalafil | Change at 4 Weeks | -1.2 | Standard Error 0.2 | units on a scale |
| Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Placebo | Change at 8 Weeks | -1.3 | Standard Error 0.2 | units on a scale |
| Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Tadalafil | Change at 8 Weeks | -1.7 | Standard Error 0.2 | units on a scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 304 | |
| Overall Study | STARTED | Tadalafil | 306 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 304 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tadalafil | 306 | |
| Overall Study | COMPLETED | Placebo | 293 | |
| Overall Study | COMPLETED | Tadalafil | 292 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Tadalafil | 14 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 304 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil | 2 | 306 | 2 |
| other | Supraventricular extrasystoles | Cardiac disorders | Placebo | 0 | 304 | 0 |
| other | Supraventricular extrasystoles | Cardiac disorders | Tadalafil | 1 | 306 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Placebo | 1 | 304 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Tadalafil | 0 | 306 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 304 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Tadalafil | 0 | 306 | 0 |
| other | Asthenopia | Eye disorders | Placebo | 0 | 304 | 0 |
| other | Asthenopia | Eye disorders | Tadalafil | 1 | 306 | 1 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Tadalafil | ||
| Total, other adverse events | Placebo | 75 | 304 |
| Total, other adverse events | Tadalafil | 87 | 306 |
| Total, serious adverse events | Placebo | 1 | 304 |
| Total, serious adverse events | Tadalafil | 2 | 306 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24571205 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tadalafil vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01460342
GET https://conductscience.org/api/trials/v1/NCT01460342/results?page=2