A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia
A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.
Inclusion criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.
Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.
Phoenix, Arizona, Arizona 86106, United States
Los Angelas, California 90017, United States
Athes, Texas 75751, United States
New Brunfels, Texas 78130, United States
Buenos Aires, Buenos Aires 1120, Argentina
Buenos Aires, Buenos Aires 1416, Argentina
Ciudad de Buenos Aires, 1118, Argentina
Ostrava - Poruba, 708 52, Czechia
Castelneau Le Nez, 34170, France
Montpelier, 34000, France
Pontonx Sur Adour, 40465, France
Saint-Egrève, 38120, France
Graefeling, Bavaria 82166, Germany
Hagenow, Brandenburg 19230, Germany
Alzenau, Hesse 63755, Germany
Koenigstein, Hesse 61462, Germany
Hohenstein-Ernsttal, Saxony 09337, Germany
Thassaloniki, 564 34, Greece
Zrifin, 70300, Israel
Castellamare Di Stabia (NA), Campania 80053, Italy
San Felice A Cancello Caserta, Campania 81027, Italy
Zapopan, Jalisco, Jalisco 45100, Mexico
S. Martinho Do Bispo, 3040-316 Coimbra, Portugal
Vigo/Pontevedra, 36200, Spain
Vizcaya, 48902, Spain
Sıhhiye/Ankara, 06100, Turkey (Türkiye)
Clydebank, Glasgow, G81 2DR, United Kingdom
Edgbaston, Birmingham, B15 2SQ, United Kingdom
Waterloo, Liverpool, L22 0LG, United Kingdom