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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: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Novartis Pharmaceuticals.
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, above the 132-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (25% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined
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 |
What the finished NCT00776009 record still lists
NCT00776009 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (25% higher).
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 lists 8 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT00776009's enrollment target sits among peer trials
165 8th of 18 higher than 11 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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