Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and PK Study of Evening Dosed Methylphenidate Hydrochloride ER Capsules (HLD200) in Children Aged 4-5 Years with ADHD
Latest Information Update: 24 Mar 2025
At a glance
- Drugs Methylphenidate (Primary)
- Indications Attention-deficit hyperactivity disorder
- Focus Therapeutic Use
- Sponsors Ironshore Pharmaceuticals (America) Inc
Most Recent Events
- 19 Mar 2025 The protocol has been amended to change in patients inclusion criteria.
- 19 Mar 2025 Planned End Date changed from 1 May 2026 to 1 Jul 2026.
- 19 Mar 2025 Planned primary completion date changed from 1 May 2026 to 1 Jul 2026.