NCT00827242CompletedPhase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 325
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)
Study Overview
Brief Summary
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
- •Provide signed informed consent at the start of the study.
- •Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
- •Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
- •Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
- •Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
- •Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
- •Demonstrate compliance with study drug administration requirements.
Exclusion Criteria
- •Treated with nitrates for a cardiac conditions.
- •Have unstable angina or angina that requires treatment.
- •Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- •Have very high or very low blood pressure
- •Have problems with kidneys, liver, or nervous system.
- •Have uncontrolled diabetes.
- •Have had a stroke or a significant injury to brain or spinal cord.
- •Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter [ng/ml] at the start of study).
Arms & Interventions
Tadalafil
Experimental
Intervention: tadalafil (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)
Time Frame: Baseline, 12 weeks
The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.
Secondary Outcomes
- Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index(Baseline, 4 weeks)
- Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index(Baseline, 12 weeks)
- Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories(12 weeks)
- Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories(12 weeks)
- Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)(Baseline, 1 week)
- Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)(Baseline, 4 Weeks)
- Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume(Baseline, 12 weeks)
Investigators
Study Sites (1)
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