Trial · NCT00848081
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
NCT00848081, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-09-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers. Trials, record NCT00848081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
- NCT number
- NCT00848081
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 318 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo
- First posted
- 2009-02-20
- Last updated
- 2010-09-14
- Results first posted
- 2010-09-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Men With Treatment-emergent Dizziness | Baseline through 12 Weeks | The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline. |
| Secondary | Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Baseline through 12 Weeks | A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of \>= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of \>=10 mmHg from the supine to standing position;(3)increase in heart rate of \>= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit. |
| Secondary | International Prostate Symptom Score (IPSS) Change From Baseline | Baseline, 12 Weeks | Change from baseline to endpoint in IPSS Score. 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. |
| Secondary | Postvoid Residual Volume (PVR) Change From Baseline | Baseline, 12 Weeks | Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination. |
| Secondary | Uroflowmetry (Qmax) Change From Baseline | Baseline, 12 Weeks | Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second \[mL/second\] using standard calibrated flowmeter). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Men With Treatment-emergent Dizziness | Baseline through 12 Weeks | Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Baseline through 12 Weeks | All randomized subjects in the analysis population with non-missing data. | Participants | NUMBER |
| SECONDARY | International Prostate Symptom Score (IPSS) Change From Baseline | Baseline, 12 Weeks | Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data. | units on a scale | MEAN |
| SECONDARY | Postvoid Residual Volume (PVR) Change From Baseline | Baseline, 12 Weeks | All randomized subjects who had non-missing baseline and endpoint data. | milliliters | MEAN |
| SECONDARY | Uroflowmetry (Qmax) Change From Baseline | Baseline, 12 Weeks | All randomized subjects with non-missing data. | milliliters per second | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Men With Treatment-emergent Dizziness | Placebo | 9 | Participants | ||
| Number of Men With Treatment-emergent Dizziness | Tadalafil | 11 | Participants | ||
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Placebo | Positive Pre-Random. to Negative Post-Random. | 22 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Tadalafil | Positive Pre-Random. to Negative Post-Random. | 15 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Placebo | Negative Pre-Random. to Positive Post-Random. | 21 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Tadalafil | Negative Pre-Random. to Positive Post-Random. | 19 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Placebo | Positive Pre-Random. to Positive Post-Random. | 14 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Tadalafil | Positive Pre-Random. to Positive Post-Random. | 16 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Placebo | Negative Pre-Random. to Negative Post-Random. | 101 | Participants | |
| Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit | Tadalafil | Negative Pre-Random. to Negative Post-Random. | 106 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 160 | |
| Overall Study | STARTED | Tadalafil | 158 | |
| Overall Study | COMPLETED | Placebo | 140 | |
| Overall Study | COMPLETED | Tadalafil | 140 | |
| Overall Study | NOT COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Tadalafil | 18 |
Source ClinicalTrials.gov
Adverse events256
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 | 1 | 160 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil | 0 | 158 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 0 | 160 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Tadalafil | 1 | 158 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 160 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Tadalafil | 1 | 158 | 1 |
| other | Cerumen impaction | Ear and labyrinth disorders | Placebo | 0 | 160 | 0 |
| other | Cerumen impaction | Ear and labyrinth disorders | Tadalafil | 1 | 158 | 1 |
| other | Deafness | Ear and labyrinth disorders | Placebo | 0 | 160 | 0 |
| other | Deafness | Ear and labyrinth disorders | Tadalafil | 1 | 158 | 1 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 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 | 53 | 160 |
| Total, other adverse events | Tadalafil | 65 | 158 |
| Total, serious adverse events | Placebo | 3 | 160 |
| Total, serious adverse events | Tadalafil | 2 | 158 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tadalafil vs Placebo: Number of Men With Treatment-emergent Dizziness | Trial comparisons |
| Tadalafil vs Placebo: serious adverse events | 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/NCT00848081
GET https://conductscience.org/api/trials/v1/NCT00848081/results?page=2