# Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

> **NCT03260205** · PHASE3 · COMPLETED · sponsor: **Shire** · enrollment: 199 (actual)

## Conditions studied

- Attention Deficit Hyperactivity Disorder (ADHD)

## Interventions

- **DRUG:** Placebo
- **DRUG:** SPD489 (Lisdexamfetamine dimesylate)
- **DRUG:** SPD489

## Key facts

- **NCT ID:** NCT03260205
- **Lead sponsor:** Shire
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-09-06
- **Primary completion:** 2018-10-23
- **Final completion:** 2018-10-23
- **Target enrollment:** 199 (ACTUAL)
- **Last updated:** 2021-06-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03260205

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03260205, "Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03260205. Licensed CC0.

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