Trial · NCT01106430

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

NCT01106430, Phase 3, Completed, Shire; results first posted 2013-06-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate. Trials, record NCT01106430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01106430

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
NCT number: NCT01106430
Status: Completed
Phases: Phase 3
Enrollment: 267 participants, actual
Lead sponsor: Shire
Conditions: Attention-Deficit/Hyperactivity Disorder
Interventions: Lisdexamfetamine Dimesylate, Atomoxetine Hydrochloride
First posted: 2010-04-19
Last updated: 2021-06-11
Other registries' IDs: eudract:2009-011745-94
Results first posted: 2013-06-24

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to First Response	9 weeks	Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Secondary	Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)	9 weeks	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF	Baseline and 9 weeks	ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
Secondary	Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks	Baseline and up to 9 weeks	The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Secondary	Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks	up to 9 weeks	HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Secondary	Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks	Baseline and up to 9 weeks	The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	9 weeks	C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Secondary	Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1	9 weeks	UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to First Response	9 weeks	Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.	Days	MEDIAN
SECONDARY	Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)	9 weeks	Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF	Baseline and 9 weeks	Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks	Baseline and up to 9 weeks	Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks	up to 9 weeks	Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	units on a scale	MEAN
SECONDARY	Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks	Baseline and up to 9 weeks	Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	units on a scale	MEAN
SECONDARY	Columbia-Suicide Severity Rating Scale (C-SSRS)	9 weeks	Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	participants	NUMBER
SECONDARY	Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1	9 weeks	Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.	participants	NUMBER

Source ClinicalTrials.gov

Results by group92

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to First Response	Lisdexamfetamine Dimesylate	12.0	95% Confidence Interval 8.0 to 16.0	Days
Time to First Response	Atomoxetine Hydrochloride	21.0	95% Confidence Interval 15.0 to 23.0	Days
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)	Lisdexamfetamine Dimesylate	81.7		percentage of participants
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)	Atomoxetine Hydrochloride	63.6		percentage of participants
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF	Lisdexamfetamine Dimesylate	-26.1	Standard Error 1.16	units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF	Atomoxetine Hydrochloride	-19.7	Standard Error 1.13	units on a scale
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks	Lisdexamfetamine Dimesylate	-0.35	Standard Error 0.034	units on a scale
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks	Atomoxetine Hydrochloride	-0.27	Standard Error 0.032	units on a scale
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks	Lisdexamfetamine Dimesylate	0.920	Standard Deviation 0.0961	units on a scale
Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks	Atomoxetine Hydrochloride	0.922	Standard Deviation 0.0937	units on a scale

1 to 10 of 92Source ClinicalTrials.gov

See all 92 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Dimesylate	133
Overall Study	STARTED	Atomoxetine Hydrochloride	134
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate	100
Overall Study	COMPLETED	Atomoxetine Hydrochloride	101
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate	33
Overall Study	NOT COMPLETED	Atomoxetine Hydrochloride	33

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL PAIN	Gastrointestinal disorders	Lisdexamfetamine Dimesylate	3	128	3
other	ABDOMINAL PAIN	Gastrointestinal disorders	Atomoxetine Hydrochloride	8	134	10
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Lisdexamfetamine Dimesylate	3	128	3
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Atomoxetine Hydrochloride	10	134	12
other	CONSTIPATION	Gastrointestinal disorders	Lisdexamfetamine Dimesylate	8	128	9
other	CONSTIPATION	Gastrointestinal disorders	Atomoxetine Hydrochloride	2	134	2
other	DIARRHOEA	Gastrointestinal disorders	Lisdexamfetamine Dimesylate	2	128	3
other	DIARRHOEA	Gastrointestinal disorders	Atomoxetine Hydrochloride	9	134	11
other	DRY MOUTH	Gastrointestinal disorders	Lisdexamfetamine Dimesylate	8	128	8
other	DRY MOUTH	Gastrointestinal disorders	Atomoxetine Hydrochloride	4	134	4

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Dimesylate
Total, all-cause mortality	Atomoxetine Hydrochloride
Total, other adverse events	Lisdexamfetamine Dimesylate	92	128
Total, other adverse events	Atomoxetine Hydrochloride	95	134
Total, serious adverse events	Lisdexamfetamine Dimesylate	0	128
Total, serious adverse events	Atomoxetine Hydrochloride	0	134

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23959815	RESULT	PubMed
25038977	DERIVED	PubMed
25999292	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lisdexamfetamine Dimesylate vs Atomoxetine Hydrochloride: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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