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Atomoxetine

Phase 2

Attention Deficit Disorder With Hyperactivity | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jul 15, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment241

FDA Designations

No designations recorded

Clinical trial landscape

Atomoxetine · 1 trial · 1 indication

Phase 2 1
NCT00174226Treatment of Adult ADHD With Atomoxetine or Atomoxetine and BusparAttention Deficit Disorder With Hyperactivity
COMPLETED241 Analytics
PHASE2COMPLETED
Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Attention Deficit Disorder With Hyperactivity
NCT00174226241
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Study Endpoints

Primary Endpoints

To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score

Secondary Endpoints

To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AtomoxetineDRUG -
BuspironeDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Adults with ADHD Exclusion Criteria: * Other Axis I Psychiatric Disorders

Countries:United States
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Frequently asked questions about Atomoxetine

What is Atomoxetine used for?

Atomoxetine is used for Attention Deficit Disorder With Hyperactivity (ADHD). It is a small molecule being developed by Pfizer, Inc. for the treatment of ADHD in adults. The drug is currently in Phase 2 clinical development, meaning it is investigational and has not yet been approved by regulatory authorities.

Who makes Atomoxetine?

Atomoxetine is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Attention Deficit Disorder With Hyperactivity (ADHD). As of the latest data, Atomoxetine is in Phase 2 development.

What phase is Atomoxetine in?

Atomoxetine is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of Attention Deficit Disorder With Hyperactivity (ADHD). The drug has not been approved by the FDA or any other regulatory agency, and its safety and efficacy have not been fully established.

What clinical trials is Atomoxetine in?

Atomoxetine has one completed clinical trial registered under NCT00174226, titled "Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar." This Phase 2 study enrolled 241 participants in the United States, with a minimum age of 18 years. The trial was randomized and double-blind, though it did not use a control group.

Is Atomoxetine the same as Buspar?

No, Atomoxetine is not the same as Buspar. Atomoxetine is a small molecule being developed by Pfizer for Attention Deficit Disorder With Hyperactivity. Buspar (buspirone) is a different medication. In a clinical trial, they were studied in combination, but they are distinct drugs with different mechanisms and uses.