Phase 2
Completed N=422
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Source: ClinicalTrials.gov NCT00783094 ↗Enrolled (actual)
422
Serious AEs
2.0%
Results posted
Jul 2010
Primary outcomePrimary: Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint — -4.5; -4.9; -3.8 units on a scale — p=0.201
Summary
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint |
-4.5; -4.9; -3.8 | 0.201 |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint |
-1.6; -1.6; -1.4 | 0.356 |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint |
-2.9; -3.3; -2.4 | 0.228 |
| SECONDARY Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint |
-0.5; -0.7; -0.4 | 0.249 |
| SECONDARY Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint |
-0.7; -0.8; -0.7 | 0.904 |
| SECONDARY Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint |
0.7; 0.6; 1.4 | 0.147 |
| SECONDARY Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement |
86.0; 169; 68.7; 140; 57.5; 93.6 | — |
| SECONDARY Number of Participants With Adverse Events During 12 Weeks of the Study |
2; 2; 1; 52; 54; 53 | — |
| SECONDARY Change From Baseline in Blood Pressure at 12-Week Endpoint |
-2.0; -3.4; -0.5; -0.7; -2.9; -0.9 | 0.342 |
| SECONDARY Change From Baseline in Sitting Heart Rate at 12-Week Endpoint |
-0.7; -1.2; 0.0 | 0.606 |
| SECONDARY Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint |
-9.41; -5.15; -4.72 | 0.428 |
| SECONDARY Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint |
0.26; 0.09; 0.14 | 0.060 |
| SECONDARY Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint |
-5.2; -5.4; -6.2 | — |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint |
-1.9; -1.6; -1.8 | — |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint |
-3.4; -3.7; -4.3 | — |
| SECONDARY Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint |
-0.8; -1.0; -0.9 | — |
| SECONDARY Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint |
-0.9; -1.0; -0.9 | — |
| SECONDARY Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint |
2.29; 1.51; 2.01 | — |
| SECONDARY Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment |
3; 4; 4; 81; 81; 94 | — |
| SECONDARY Change From Baseline in Blood Pressure During at 54-Week Endpoint |
-2.1; -1.2; -0.5; -1.6; -2.9; -1.3 | — |
| SECONDARY Change From Baseline in Sitting Heart Rate at 54-Week Endpoint |
1.4; 0.4; 2.1 | — |
| SECONDARY Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint |
0.4; 0.3; 0.3 | — |
| SECONDARY Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint |
-5.7; -1.9; -5.5 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
- Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or 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 Visit 2.
Exclusion Criteria
- Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
- History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
- Clinical evidence of prostate cancer at Visit 1.
- Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
- 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 (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
- Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Data sourced from ClinicalTrials.gov (NCT00783094). 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. Informational only — not medical advice.