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NCT02578030
Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
Phase 1 trial testing SHP465 12.5mg in Attention Deficit Hyperactivity Disorder (ADHD) in 27 participants. Completed in 10 November 2015.
10 November 2015
Quick facts
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 24 October 2015 |
| Primary completion | 10 November 2015 |
| Estimated completion | 10 November 2015 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- SHP465 12.5mg — full drug profile →
- SHP465 25mg — full drug profile →
Conditions studied
- Attention Deficit Hyperactivity Disorder (ADHD) — all drugs for Attention Deficit Hyperactivity Disorder (ADHD) →
Sponsor
Shire — full company profile →
Who can join
Adults 6 to 17, any sex, with Attention Deficit Hyperactivity Disorder (ADHD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Amphetamines in child medicine: a review of ClinicalTrials.gov.
Alalalmeh SO, Hegazi OE, Shahwan M, Alshehri FS, et al · · 2023 · cited 1× · PMID 37854716 · DOI 10.3389/fphar.2023.1280562
Verify or expand the search:
- PubMed search for NCT02578030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Attention Deficit Hyperactivity Disorder (ADHD)
Currently open trials in the same condition.
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- NCT06960980 — Improving ADHD Teen Driving - Virtual Reality · NA · recruiting
- NCT06810180 — Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Het · NA · recruiting
- NCT06885060 — Exploring Eye Vergence Markers ADHD) and ASD · active not recruiting
Other Shire trials
Trials by the same sponsor.
- NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
- NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
- NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
- NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
- NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02578030 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shire
- Last refreshed: 18 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02578030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing