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NCT01259492 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study of Attention Deficit Hyperactivity Disorder, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 725
- Enrollment target
- 20
- Study locations
NCT01259492: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder, sponsored by Novartis Pharmaceuticals.
NCT01259492 is a Phase 3 study of Attention Deficit Hyperactivity Disorder that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 725 participants, above the 209-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259492, a Phase 3 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 725 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).
Primary Outcome
Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("Never") to 4 ("Very often"). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefor
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ritalin LA 20 mg
- DRUG Ritalin LA 30 mg
Study Locations (20)
Florida
- Novartis Investigative Site - Bradenton
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Orlando
- Novartis Investigative Site - West Plam Beach
California
- Novartis Investigative Site - Beverly Hills
- Novartis Investigative Site - Spring Valley
Nevada
- Novartis Investigative Site - Las Vegas
- Novartis Investigative Site - Las Vegas
Texas
- Novartis Investigative Site - Houston
- Novartis Investigative Site - Houston
Arkansas
- Novartis Investigative Site - Little Rock
Illinois
- Novartis Investigative Site - Libertyville
Kentucky
- Novartis Investigative Site - Owensboro
Michigan
- Novartis Investigative Site - Troy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01259492 record still lists
NCT01259492 is an interventional study that assigns participants to a tested intervention. The registered 725 participants enrollment target is mid-sized for trials with a published cap, above the 209-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (247% higher).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01259492 names 20 study sites across 14 states, led by Florida, California, Nevada.
Frequently Asked Questions
What is clinical trial NCT01259492 about?
NCT01259492 is a clinical study titled "Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)". This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).
What is the current status of trial NCT01259492?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2010-11. Estimated completion is 2012-08.
What conditions does trial NCT01259492 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT01259492?
The interventions under investigation include: Placebo (DRUG), Ritalin LA 20 mg (DRUG), Ritalin LA 30 mg (DRUG).
Who is sponsoring clinical trial NCT01259492?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01259492 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01259492's enrollment target sits among peer trials
725 6th of 102 higher than 97 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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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