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NCT00776009 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
A Phase 4 study of Attention Deficit/Hyperactivity Disorder (ADHD), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 165
- Enrollment target
- 8
- Study locations
NCT00776009 is a Phase 4 study of Attention Deficit/Hyperactivity Disorder (ADHD) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 165 participants. The trial reports 8 study locations across 5 states.
The verdict
NCT00776009, a Phase 4 study of Attention Deficit/Hyperactivity Disorder (ADHD), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 165 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
Study Locations (8)
Texas
- Bayou City Research - Houston
- Claghorn-Lesem Research Clinic - Houston
- Behavioral Neurology - Lubbock
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Miami Research Associates - South Miami
Arkansas
- Clinical Study Center, LLC - Little Rock
Kansas
- Vince and Associates Clinical Research - Overland Park
Nevada
- Center for Psychiatry and Behavioral Medicine, Inc. - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2008-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00776009
The ClinicalTrials.gov registry entry for NCT00776009 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit/Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00776009 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Texas, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00776009 about?
NCT00776009 is a clinical study titled "Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.". This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.
What is the current status of trial NCT00776009?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 165 participants. The study started on 2008-10. Estimated completion is 2008-12.
What conditions does trial NCT00776009 study?
This clinical trial studies the following conditions: Attention Deficit/Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT00776009?
The interventions under investigation include: Placebo (DRUG), Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) (DRUG).
Who is sponsoring clinical trial NCT00776009?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00776009 being conducted?
This trial has 8 study locations across Arkansas, Florida, Kansas, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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