A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
|ClinicalTrials.gov Identifier: NCT00848081|
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : September 14, 2010
Last Update Posted : September 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: Tadalafil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||318 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Placebo Comparator: Placebo||
By mouth once daily for 12 weeks
5 mg taken by mouth once daily for 12 weeks
- Number of Men With Treatment-emergent Dizziness [ Time Frame: 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.
- Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit [ Time Frame: 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.
- International Prostate Symptom Score (IPSS) Change From Baseline [ Time Frame: 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.
- Postvoid Residual Volume (PVR) Change From Baseline [ Time Frame: 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.
- Uroflowmetry (Qmax) Change From Baseline [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848081
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|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM- 5 PM Eastern time (UTC/GMT -5 hourse, EST)||Eli Lilly and Company|