An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)
Phase of Trial: Phase III
Latest Information Update: 11 Oct 2017
At a glance
- Drugs Mirabegron (Primary)
- Indications Overactive bladder
- Focus Therapeutic Use
- Acronyms Crocodile
- Sponsors Astellas Pharma
- 17 Aug 2017 Planned End Date changed from 31 Aug 2019 to 1 Aug 2019.
- 17 Aug 2017 Planned primary completion date changed from 15 Feb 2019 to 1 Feb 2019.
- 23 May 2017 Planned primary completion date changed from 1 Aug 2019 to 15 Feb 2019.