A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Phase of Trial: Phase IV
Latest Information Update: 31 Aug 2017
At a glance
- Drugs Mirabegron (Primary) ; Tamsulosin
- Indications Benign prostatic hyperplasia; Lower urinary tract symptoms; Overactive bladder
- Focus Therapeutic Use
- Acronyms PLUS PLUS
- Sponsors Astellas Pharma
- 15 Aug 2017 Planned End Date changed from 31 Mar 2018 to 1 Mar 2018.
- 15 Aug 2017 Planned primary completion date changed from 3 Mar 2018 to 1 Mar 2018.
- 09 May 2017 Planned End Date changed from 1 Nov 2018 to 31 Mar 2018.