At a glance
ClinicalIndex Comparison Record- ✓Male, aged ≥50 years
- ✓Clinical diagnosis of BPH by history and physical examination including DRE
- ✓International Prostate Symptom Score (IPSS) ≥12 points at Screening
- ✓Prostate volume ≥30 cc by transrectal ultrasonography (TRUS)
- ✕Total serum PSA >10.0 ng/mL at Screening
- ✕History or evidence of prostate cancer (positive biopsy, suspicious ultrasound, or suspicious DRE), except patients with negative biopsy within 6 months and stable PSA
- ✕Previous prostatic surgery (TURP, balloon dilatation, thermotherapy, stent) or other invasive BPH procedures
- ✕History of flexible/rigid cystoscopy or other urethral instrumentation within 7 days prior to Screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating dutasteride 0.5mg once daily for 4 years and tamsulosin 0.4mg once daily for 4 years for Prostatic Hyperplasia. Completed, enrolled 4,844 participants across 503 sites in 36 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
combination or single agent
combination agent or single agent