Trials / Terminated
TerminatedNCT04987762
Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children
An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children 4 to 12 Years of Age
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Purdue Pharma LP · Industry
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adhansia XR | Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg) |
Timeline
- Start date
- 2021-08-03
- Primary completion
- 2022-04-27
- Completion
- 2022-04-27
- First posted
- 2021-08-03
- Last updated
- 2023-08-22
- Results posted
- 2023-08-22
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04987762. Inclusion in this directory is not an endorsement.