Trial · NCT00861757
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
NCT00861757, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia. Trials, record NCT00861757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00861757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
- NCT number
- NCT00861757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 612 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo, Tamsulosin
- First posted
- 2009-03-13
- Last updated
- 2011-06-28
- Results first posted
- 2011-06-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | baseline, 12 weeks | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. |
| Secondary | Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | baseline, 12 weeks | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. |
| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks | baseline, 12 weeks | Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. |
| Secondary | Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks | baseline, 12 weeks | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value. |
| Secondary | Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks | baseline, 12 weeks | Qmax: defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value. |
| Secondary | Patient Global Impression of Improvement (PGI-I) at Week 12 | 12 weeks | The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). |
| Secondary | Clinician Global Impression of Improvement (CGI-I) at Week 12 | 12 weeks | The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). |
| Secondary | Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks | baseline, 12 weeks | Nanograms of PSA per milliliter (ng/mL) of blood. |
| Secondary | Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks | baseline, 12 weeks | The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound. |
| Secondary | Change From Baseline in Blood Pressure (Sitting) at 12 Weeks | baseline, 12 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 International Prostate Symptom Score (IPSS) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | milliliter per second (mL/sec) | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I) at Week 12 | 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | Participants | NUMBER |
| SECONDARY | Clinician Global Impression of Improvement (CGI-I) at Week 12 | 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | participants | NUMBER |
| SECONDARY | Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | microgram/Liter | MEAN |
| SECONDARY | Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | milliliter (mL) | MEAN |
| SECONDARY | Change From Baseline in Blood Pressure (Sitting) at 12 Weeks | baseline, 12 weeks | The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis. | mm Hg | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group108
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 International Prostate Symptom Score (IPSS) at 12 Weeks | Placebo | -3.0 | Standard Error 0.4 | Units on a scale | |
| Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | 2.5 mg Tadalafil | -4.8 | Standard Error 0.4 | Units on a scale | |
| Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | 5 mg Tadalafil | -4.7 | Standard Error 0.4 | Units on a scale | |
| Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | 0.2 mg Tamsulosin | -5.5 | Standard Error 0.4 | Units on a scale | |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | Placebo | Voiding (Obstructive) Score (N = 154,151,155,152) | -1.9 | Standard Error 0.3 | units on a scale |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | 2.5 mg Tadalafil | Voiding (Obstructive) Score (N = 154,151,155,152) | -3.3 | Standard Error 0.3 | units on a scale |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | 5.0 mg Tadalafil | Voiding (Obstructive) Score (N = 154,151,155,152) | -3.0 | Standard Error 0.3 | units on a scale |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | 0.2 mg Tamsulosin | Voiding (Obstructive) Score (N = 154,151,155,152) | -3.8 | Standard Error 0.3 | units on a scale |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | Placebo | Storage (Irritative) Score (N = 154,151,155,152) | -1.1 | Standard Error 0.2 | units on a scale |
| Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) | 2.5 mg Tadalafil | Storage (Irritative) Score (N = 154,151,155,152) | -1.5 | Standard Error 0.2 | units on a scale |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 154 | |
| Overall Study | STARTED | 2.5 mg Tadalafil | 151 | |
| Overall Study | STARTED | 5.0 mg Tadalafil | 155 | |
| Overall Study | STARTED | 0.2 mg Tamsulosin | 152 | |
| Overall Study | COMPLETED | Placebo | 145 | |
| Overall Study | COMPLETED | 2.5 mg Tadalafil | 136 | |
| Overall Study | COMPLETED | 5.0 mg Tadalafil | 137 | |
| Overall Study | COMPLETED | 0.2 mg Tamsulosin | 143 | |
| Overall Study | NOT COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | 2.5 mg Tadalafil | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events436
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 | Arrhythmia | Cardiac disorders | Placebo | 0 | 154 | 0 |
| other | Arrhythmia | Cardiac disorders | 2.5 mg Tadalafil | 0 | 151 | 0 |
| other | Arrhythmia | Cardiac disorders | 5.0 mg Tadalafil | 0 | 155 | 0 |
| other | Arrhythmia | Cardiac disorders | 0.2 mg Tamsulosin | 1 | 152 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 154 | 1 |
| other | Palpitations | Cardiac disorders | 2.5 mg Tadalafil | 1 | 151 | 1 |
| other | Palpitations | Cardiac disorders | 5.0 mg Tadalafil | 1 | 155 | 1 |
| other | Palpitations | Cardiac disorders | 0.2 mg Tamsulosin | 0 | 152 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 0 | 154 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | 2.5 mg Tadalafil | 0 | 151 | 0 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 2.5 mg Tadalafil | ||
| Total, all-cause mortality | 5.0 mg Tadalafil | ||
| Total, all-cause mortality | 0.2 mg Tamsulosin | ||
| Total, other adverse events | Placebo | 24 | 154 |
| Total, other adverse events | 2.5 mg Tadalafil | 38 | 151 |
| Total, other adverse events | 5.0 mg Tadalafil | 42 | 155 |
| Total, other adverse events | 0.2 mg Tamsulosin | 35 | 152 |
| Total, serious adverse events | Placebo | 1 | 154 |
| Total, serious adverse events | 2.5 mg Tadalafil | 4 | 151 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00861757
GET https://conductscience.org/api/trials/v1/NCT00861757/results?page=2