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Atomoxetine/d

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Mar 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment430

FDA Designations

No designations recorded

Clinical trial landscape

Atomoxetine/d · 1 trial · 1 indication

Phase 2 1
NCT00880217A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
COMPLETED430 Analytics
PHASE2COMPLETED
A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the ADHD rating scale total score
Through Day 42

Secondary Endpoints

Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
At the end of the double-blind treatment phase (Day 42)
Other secondary endpoints will include the change from baseline in the Conners Adult ADHD Rating Scale (CAARS-S:SV) and the Clinical Global Impression - Severity (CGI-S).
Through the end of the double-blind treatment phase (Day 42)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days
002EXPERIMENTALJNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days
003EXPERIMENTALJNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days
004ACTIVE_COMPARATORAtomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days
005ACTIVE_COMPARATOROROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days
006PLACEBO_COMPARATORPlacebo capsule once daily for 42 days

Interventions

NameTypeDescription
Atomoxetine 80 mg/dDRUG40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
PlaceboDRUGPlacebo capsule once daily for 42 days
OROS methylphenidate HCl 54 mg/dDRUG36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
JNJ-31001074 3 mg/dDRUG3-mg capsule once daily for 42 days
JNJ-31001074 1 mg/dDRUG1-mg capsule once daily for 42 days
JNJ-31001074 10 mg/dDRUG10-mg capsule once daily for 42 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Patients diagnosed with ADHD, confirmed with the Conners Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual, 4th edition (DSM-IV) (CAADID) * Patients who meet the cutoff scores for the Conners Adult ADHD Rating Scale (CAARS-S:SV) * Patients with a Clinical G...

Countries:United States
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Frequently asked questions about Atomoxetine/d

What is Atomoxetine/d used for?

Atomoxetine/d is an investigational small molecule being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Atomoxetine/d?

Atomoxetine/d is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 2 clinical trials for Attention Deficit Hyperactivity Disorder.

What phase is Atomoxetine/d in?

Atomoxetine/d is in Phase 2 clinical development. It is an investigational drug for Attention Deficit Hyperactivity Disorder and has not yet received regulatory approval. One Phase 2 trial has been completed.

What clinical trials is Atomoxetine/d in?

Atomoxetine/d has one completed clinical trial, NCT00880217, which evaluated three different doses of JNJ-31001074 in adults with Attention Deficit Hyperactivity Disorder. The trial was a randomized, double-blind, placebo-controlled study with 430 participants in the United States.

Is Atomoxetine/d the same as JNJ-31001074?

Yes, Atomoxetine/d is also known as JNJ-31001074. The clinical trial NCT00880217, which studied the drug for Attention Deficit Hyperactivity Disorder, refers to it by this alternative name.