Phase 3
N=612
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00861757 ↗Enrolled (actual)
612
Serious AEs
0.8%
Results posted
Jun 2011
Primary outcome: Primary: Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks — -3.0; -4.8; -4.7; -5.5 Units on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tadalafil (Drug); Placebo (Drug); Tamsulosin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks |
-3.0; -4.8; -4.7; -5.5 | 0.003 sig |
| SECONDARY Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive]) |
-1.9; -3.3; -3.0; -3.8; -1.1; -1.5 | <0.001 sig |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks |
-0.5; -0.8; -0.8; -1.1 | 0.031 sig |
| SECONDARY Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks |
-0.8; -1.1; -1.0; -1.6 | 0.201 |
| SECONDARY Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks |
2.1; 1.6; 1.3; 2.1 | 0.331 |
| SECONDARY Patient Global Impression of Improvement (PGI-I) at Week 12 |
2; 1; 1; 0; 3; 1 | <0.001 sig |
| SECONDARY Clinician Global Impression of Improvement (CGI-I) at Week 12 |
0; 2; 0; 0; 3; 3 | 0.034 sig |
| SECONDARY Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks |
-0.03; 0.04; 0.13; -0.06 | 0.412 |
| SECONDARY Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks |
-1.20; -0.09; -2.90; -5.67 | 0.688 |
| SECONDARY Change From Baseline in Blood Pressure (Sitting) at 12 Weeks |
0.9; -2.3; -0.5; 0.2; -0.3; -2.5 | 0.005 sig |
| SECONDARY Change From Baseline in Blood Pressure (Standing) at 12 Weeks |
0.8; -2.9; 0.6; -0.9; 0.4; -2.3 | 0.007 sig |
| SECONDARY Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks |
-0.3; 0.7; 0.6; 0.6 | 0.330 |
Summary
This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).
Eligibility Criteria
Inclusion Criteria
- Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
- Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
- Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment
Exclusion Criteria
- Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
- History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
- History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
- Clinical evidence of prostate cancer at initiation
- Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
- History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
- History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
- Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Data sourced from ClinicalTrials.gov (NCT00861757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.