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Mixed salts of a single-entity amphetamine

Phase 3

Attention Deficit Disorder With Hyperactivity | Small molecule | Psychiatry |Takeda Pharmaceutical Company Limited|Last Updated: May 25, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Mixed salts of a single-entity amphetamine · 1 trial · 1 indication

Phase 3 1
NCT00557960ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHDAttention Deficit Disorder With Hyperactivity
COMPLETED36 Analytics
PHASE3COMPLETED
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Attention Deficit Disorder With HyperactivityUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Driving Safety Score derived by the driving simulator
Weeks 3 & 6

Secondary Endpoints

Driving Safety Scores at individual time points
2, 7, and 12 hours post-dose at Weeks 3 & 6
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Weeks 3 & 6
AEs, laboratory screens, PE, vital signs, ECG
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Mixed salts of a single-entity amphetamineDRUG -
Atomoxetine hydrochlorideDRUG -
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Eligibility Criteria

Age Range19 Years to 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * primary diagnosis of ADHD * not naive to pharmacologic ADHD treatment * valid driver's license with a minimum of 3 years driving experience Exclusion Criteria: * recent history of drug dependence or substance use disorder * any specific cardiac condition that would, in the o...

Countries:United States
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Frequently asked questions about Mixed salts of a single-entity amphetamine

What is Mixed salts of a single-entity amphetamine used for?

Mixed salts of a single-entity amphetamine is used for Attention Deficit Disorder With Hyperactivity (ADHD). It is a small molecule being developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 3 clinical development for this indication.

Who makes Mixed salts of a single-entity amphetamine?

Takeda Pharmaceutical Company Limited (ticker: TAK) is the developer of Mixed salts of a single-entity amphetamine. The drug is being studied for the treatment of Attention Deficit Disorder With Hyperactivity. It is currently in Phase 3 clinical trials.

What phase is Mixed salts of a single-entity amphetamine in?

Mixed salts of a single-entity amphetamine is in Phase 3 clinical development. It is an investigational drug being studied for Attention Deficit Disorder With Hyperactivity. The drug has completed one Phase 3 trial and is not yet approved.

What clinical trials is Mixed salts of a single-entity amphetamine in?

Mixed salts of a single-entity amphetamine has one completed Phase 3 trial, NCT00557960. This trial compared the drug and atomoxetine hydrochloride to placebo on simulated driving safety and cognitive functioning in adults with ADHD. The study enrolled 36 participants in the United States.

Is Mixed salts of a single-entity amphetamine FDA approved?

Mixed salts of a single-entity amphetamine is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Attention Deficit Disorder With Hyperactivity. The drug has completed one Phase 3 trial but has not received regulatory approval.