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Dexmethylphenidate

Phase 3

ADHD, ADD | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 21, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment252

FDA Designations

No designations recorded

Clinical trial landscape

Dexmethylphenidate · 1 trial · 1 indication

Phase 3 1
NCT00301236Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity DisorderADHD, ADD
COMPLETED252 Analytics
PHASE3COMPLETED
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
ADHD, ADDUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.

Secondary Endpoints

Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Dexmethylphenidate HCl extended-release capsulesDRUG -
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Eligibility Criteria

Age Range6 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term Exclusion Criteria: * Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical con...

Countries:United States
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Frequently asked questions about Dexmethylphenidate

What is Dexmethylphenidate used for?

Dexmethylphenidate is used for the treatment of attention-deficit/hyperactivity disorder (ADHD) and attention deficit disorder (ADD) in children. It is a small molecule being developed by Novartis AG for these psychiatric conditions.

Who makes Dexmethylphenidate?

Dexmethylphenidate is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is Dexmethylphenidate in?

Dexmethylphenidate is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 3 trial has been completed.

What clinical trials is Dexmethylphenidate in?

Dexmethylphenidate has one completed Phase 3 trial, NCT00301236, titled "Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder." The trial enrolled 252 participants in the United States.

Is Dexmethylphenidate the same as dexmethylphenidate hydrochloride?

Dexmethylphenidate is the drug name, and the clinical trial refers to it as dexmethylphenidate HCl, which stands for dexmethylphenidate hydrochloride. These names refer to the same compound.