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NCT00866996
A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder
Phase 4 trial testing Methylphenidate extended-release; Atomoxetine in Attention Deficit Hyperactivity Disorder in 1,323 participants. Completed in 1 December 2003.
Quick facts
| Lead sponsor | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,323 |
| Estimated completion | 1 December 2003 |
Drugs / interventions tested
- Methylphenidate extended-release; Atomoxetine — full drug profile →
Conditions studied
- Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
Sponsor
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. — full company profile →
Who can join
Adults 6 to 12, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.
Sponsor's own description
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00866996
- 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
Currently open trials in the same condition.
- NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact · Phase 1 · recruiting
- NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure · NA · recruiting
- NCT06325813 — ADHD PreSMA Response Inhibition Therapy · NA · recruiting
- NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting
- NCT06232226 — Attention Deficit Hyperactivity Disorder · NA · recruiting
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 NCT00866996 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Last refreshed: 20 May 2011
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/NCT00866996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing