Trial · NCT00763971

Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

NCT00763971, Phase 3, Completed, Shire; results first posted 2012-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17. Trials, record NCT00763971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00763971

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Trial

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

Title: Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
NCT number: NCT00763971
Status: Completed
Phases: Phase 3
Enrollment: 336 participants, actual
Lead sponsor: Shire
Conditions: ADHD
Interventions: Lisdexamfetamine Dimesylate (LDX), Methylphenidate Hydrochloride, Placebo
First posted: 2008-10-01
Last updated: 2021-06-14
Other registries' IDs: eudract:2008-000679-90
Results first posted: 2012-03-22

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks	Baseline and up to 7 weeks	The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging 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	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 7 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 Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks	Baseline and up to 7 weeks	The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Secondary	Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks	Baseline and up to 7 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 the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks	Baseline and up to 7 weeks	The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
Secondary	Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks	Baseline and up to 7 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	Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks	Baseline and up to 7 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)	Up to 7 weeks	C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.

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	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks	Baseline and up to 7 weeks	Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 7 weeks	FAS	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks	Baseline and up to 7 weeks	FAS	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks	Baseline and up to 7 weeks	FAS	Scores on a scale	MEAN
SECONDARY	Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks	Baseline and up to 7 weeks	FAS	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks	Baseline and up to 7 weeks	FAS	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks	Baseline and up to 7 weeks	Safety Population defined as all subjects who took at least 1 dose of investigational product.	Scores on a scale	MEAN
SECONDARY	Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 7 weeks	Safety Population	participants	NUMBER

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks	Lisdexamfetamine Dimesylate (LDX)		-24.3	Standard Error 1.16	Scores on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks	Methylphenidate Hydrochloride		-18.7	Standard Error 1.14	Scores on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks	Placebo		-5.7	Standard Error 1.13	Scores on a scale
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Lisdexamfetamine Dimesylate (LDX)		78.0		percentage of participants
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Methylphenidate Hydrochloride		60.6		percentage of participants
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Placebo		14.4		percentage of participants
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks	Lisdexamfetamine Dimesylate (LDX)		-24.5	Standard Error 1.70	Scores on a scale
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks	Methylphenidate Hydrochloride		-18.4	Standard Error 1.69	Scores on a scale
Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks	Placebo		-3.2	Standard Error 1.69	Scores on a scale
Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks	Lisdexamfetamine Dimesylate (LDX)	Baseline	0.811	Standard Deviation 0.1451	Scores on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Dimesylate (LDX)	113
Overall Study	STARTED	Methylphenidate Hydrochloride	112
Overall Study	STARTED	Placebo	111
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate (LDX)	80
Overall Study	COMPLETED	Methylphenidate Hydrochloride	74
Overall Study	COMPLETED	Placebo	42
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate (LDX)	33
Overall Study	NOT COMPLETED	Methylphenidate Hydrochloride	38
Overall Study	NOT COMPLETED	Placebo	69

Source ClinicalTrials.gov

Adverse events105

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 (LDX)	6	111	6
other	Abdominal pain	Gastrointestinal disorders	Methylphenidate Hydrochloride	4	111	4
other	Abdominal pain	Gastrointestinal disorders	Placebo	6	110	10
other	Abdominal upper pain	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	8	111	15
other	Abdominal upper pain	Gastrointestinal disorders	Methylphenidate Hydrochloride	9	111	10
other	Abdominal upper pain	Gastrointestinal disorders	Placebo	6	110	9
other	Diarrhea	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	5	111	8
other	Diarrhea	Gastrointestinal disorders	Methylphenidate Hydrochloride	2	111	2
other	Diarrhea	Gastrointestinal disorders	Placebo	3	110	3
other	Nausea	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	12	111	14

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Dimesylate (LDX)
Total, all-cause mortality	Methylphenidate Hydrochloride
Total, all-cause mortality	Placebo
Total, other adverse events	Lisdexamfetamine Dimesylate (LDX)	80	111
Total, other adverse events	Methylphenidate Hydrochloride	72	111
Total, other adverse events	Placebo	63	110
Total, serious adverse events	Lisdexamfetamine Dimesylate (LDX)	3	111
Total, serious adverse events	Methylphenidate Hydrochloride	2	111
Total, serious adverse events	Placebo	3	110

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23332456	RESULT	PubMed
23708466	RESULT	PubMed
23893527	RESULT	PubMed
26409610	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 comparisons0

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

None in this release.

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.

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Read this trial from software.

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

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