ADDERALL XR (Mixed Salts of a Single-entity Amphetamine)... | NCT00557960

Studies
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

NCT00557960

Sponsor

Shire

Status

Completed

Last Update Posted

May 25, 2021Actual

Enrollment

36Actual

Phase

Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Mixed salts of a single-entity amphetamine
Atomoxetine hydrochloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2004Actual

Primary Completion Date

Oct 25, 2004Actual

Completion Date

Oct 25, 2004Actual

First Submitted Date

Nov 9, 2007

First Submission Date that Met QC Criteria

Nov 12, 2007

First Posted Date

Nov 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2021

Last Update Posted Date

May 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Name	Type	Description	Arm Group Labels	Other Names
Mixed salts of a single-entity amphetamine	Drug			ADDERALL XR
Atomoxetine hydrochloride	Drug			STRATTERA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Driving Safety Score derived by the driving simulator		Weeks 3 & 6

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 opinion of the investigator, require exclusion
history of seizure in last 2 years, tic disorder or Tourette's disorder
female subject is pregnant or lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Takeda	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Neuropsychological Institute, LLC		Washington D.C.	District of Columbia		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18815438	Result	Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
C449521	SLI381
D000069445	Atomoxetine Hydrochloride

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals