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Label indication CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions… FDA label
Also known as CONCERTA (OROS methylphenidate hydrochloride), Long-Acting Methylphenidate, OROS Methylphenidate HCl
Concerta · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| CONCERTA (OROS methylphenidate hydrochloride) | DRUG | - |
Inclusion Criteria: * Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Diseases (DSM-IV) obtained via clinical interview and confirmed by the Wender Utah Rating Scale * ADHD symptoms from childhood to adulthood, with so...
Concerta is used to treat Attention Deficit Disorder With Hyperactivity. It is a small molecule therapy studied in adults aged 18 years and older with this condition. The clinical program for Concerta in this indication has focused on patients diagnosed with Attention Deficit Disorder With Hyperactivity.
Concerta is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor associated with the clinical development of Concerta, also known as OROS methylphenidate hydrochloride, for Attention Deficit Disorder With Hyperactivity.
Concerta has been studied in Phase 3 clinical development for Attention Deficit Disorder With Hyperactivity. The Phase 3 trial in this program is listed as completed, and no trials for Concerta are currently active. Concerta is an investigational therapy in this development context.
Concerta has been evaluated in the Phase 3 trial NCT00246207, titled CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults. That trial enrolled 32 participants, was uncontrolled, and is now completed. No other trials of Concerta are listed as active.
Yes. Concerta is also known as OROS methylphenidate hydrochloride. The two names refer to the same therapy, which is a small molecule developed by Johnson & Johnson for Attention Deficit Disorder With Hyperactivity. Searches for either name point to the same clinical program.
The Phase 3 trial NCT00246207 studied Concerta, or OROS methylphenidate hydrochloride, for the treatment of Attention Deficit Disorder With Hyperactivity in adults. It enrolled 32 participants aged 18 years and older, was uncontrolled, and did not use randomization or double blinding. The trial is completed.