Trial · NCT00735371

Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00735371, Phase 3, Completed, Shire; results first posted 2010-02-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00735371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00735371

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Trial

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

Title: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT number: NCT00735371
Status: Completed
Phases: Phase 3
Enrollment: 314 participants, actual
Lead sponsor: Shire
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Interventions: LDX 30 mg, LDX 50 mg, LDX 70 mg, Placebo
First posted: 2008-08-14
Last updated: 2021-06-14
Results first posted: 2010-02-23

Source ClinicalTrials.gov

Registered outcomes3

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 4 Weeks	Baseline and 1, 2, 3 and 4 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.
Secondary	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	1, 2, 3 and 4 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	Youth Quality of Life-Research Version (YQOL-R) Total Score	Baseline and 4 weeks	The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.

Source ClinicalTrials.gov

Outcomes3

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 4 Weeks	Baseline and 1, 2, 3 and 4 weeks	Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	1, 2, 3 and 4 Weeks	FAS	Participants	NUMBER
SECONDARY	Youth Quality of Life-Research Version (YQOL-R) Total Score	Baseline and 4 weeks	FAS	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group16

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 4 Weeks	Lisdexamfetamine Dimesylate (LDX) 30 mg		-18.3	Standard Error 1.25	Units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks	LDX 50 mg		-21.1	Standard Error 1.28	Units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks	LDX 70 mg		-20.7	Standard Error 1.25	Units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks	Placebo		-12.8	Standard Error 1.25	Units on a scale
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Lisdexamfetamine Dimesylate (LDX) 30 mg		44		Participants
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	LDX 50 mg		53		Participants
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	LDX 70 mg		57		Participants
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Placebo		30		Participants
Youth Quality of Life-Research Version (YQOL-R) Total Score	Lisdexamfetamine Dimesylate (LDX) 30 mg	Baseline	79.3	Standard Deviation 10.03	Units on a scale
Youth Quality of Life-Research Version (YQOL-R) Total Score	LDX 50 mg	Baseline	80.5	Standard Deviation 10.63	Units on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Dimesylate (LDX) 30 mg	78
Overall Study	STARTED	LDX 50 mg	79
Overall Study	STARTED	LDX 70 mg	78
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate (LDX) 30 mg	63
Overall Study	COMPLETED	LDX 50 mg	66
Overall Study	COMPLETED	LDX 70 mg	67
Overall Study	COMPLETED	Placebo	69
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate (LDX) 30 mg	15
Overall Study	NOT COMPLETED	LDX 50 mg	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

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
other	Decreased appetite	Metabolism and nutrition disorders	Lisdexamfetamine Dimesylate (LDX) 30 mg	29	78
other	Decreased appetite	Metabolism and nutrition disorders	LDX 50 mg	21	77
other	Decreased appetite	Metabolism and nutrition disorders	LDX 70 mg	29	78
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	2	77
other	Headache	Nervous system disorders	Lisdexamfetamine Dimesylate (LDX) 30 mg	9	78
other	Headache	Nervous system disorders	LDX 50 mg	13	77
other	Headache	Nervous system disorders	LDX 70 mg	12	78
other	Headache	Nervous system disorders	Placebo	10	77
other	Insomnia	Psychiatric disorders	Lisdexamfetamine Dimesylate (LDX) 30 mg	7	78
other	Insomnia	Psychiatric disorders	LDX 50 mg	8	77

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Dimesylate (LDX) 30 mg
Total, all-cause mortality	LDX 50 mg
Total, all-cause mortality	LDX 70 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Lisdexamfetamine Dimesylate (LDX) 30 mg	51	78
Total, other adverse events	LDX 50 mg	53	77
Total, other adverse events	LDX 70 mg	56	78
Total, other adverse events	Placebo	38	77
Total, serious adverse events	Lisdexamfetamine Dimesylate (LDX) 30 mg	0	78
Total, serious adverse events	LDX 50 mg	0	77

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21421179	RESULT

Source 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.

For software

Read this trial from software.

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

GET https://conductscience.org/api/trials/v1/NCT00735371

GET https://conductscience.org/api/trials/v1/NCT00735371/events?page=2

API reference For AI assistants