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HLD100 PK/PD in Pediatric ADHD
NCT01886469Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Sep 2013
- Countries
- 1
- Sponsor
- Ironshore Pharmaceuticals
- Modality
- Device-based Delivery, Orthosteric Ligands
- Drugs
- HLD100-E
- Conditions
- attention deficit hyperactivity disorder (ADHD)
01
Overview
Phase 2, open-label trial of HLD100-E in attention deficit hyperactivity disorder (ADHD) (2 arms), sponsored by Ironshore Pharmaceuticals. Primary endpoints: Area Under the Curve at 48 hours, Maximum Plasma Concentration at 48 hours and 1 more. Started Jul 2013; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Adolescents (12-17yrs)
Adolescents receiving HLD100 formulations
Children (6-11 yrs)
Children receiving HLD100 formulations
03
Endpoints
Primary
Area Under the Curve
Maximum Plasma Concentration
Time to Maximum Concentration
Secondary
Safety Assessment
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