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Dutasteride and Tamsulosin Combination vs Tamsulosin Monotherapy in Asian Men with BPH
NCT02058368Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2014
- Primary completion
- Mar 2017
- Countries
- 4
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- dutasteride
- Conditions
- benign prostatic hyperplasia (BPH)
01
Overview
Phase 3, randomised, double-blind trial of dutasteride in benign prostatic hyperplasia (BPH) (2 arms), sponsored by GSK. Primary endpoint: Change From Baseline in International Prostate Symptom Score at 24 months. Started Feb 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dutasteride + Tamsulosin
Dutasteride 0.5mg + Tamsulosin 0.2mg OD
Tamsulosin Monotherapy
Placebo Dutasteride + Tamsulosin 0.2mg OD
03
Endpoints
Primary
Change From Baseline in International Prostate Symptom Score
Secondary
Percent Change in Prostate Volume From Baseline
Number of Participants With IPSS Improvement From Baseline
Change From Baseline in Maximum Urine Flow Rate
Number of Participants With Acute Urinary Retention or BPH-Related Prostatic Surgery
Change From Baseline in BPH-related Health Status
Change From Baseline in BPH Impact Index
Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory
Change From Baseline in Serum Prostate Specific Antigen
04
Results
Primary endpoints met
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