Trial · NCT01552902

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

NCT01552902, Phase 4, Completed, Shire; results first posted 2015-03-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder. Trials, record NCT01552902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01552902

On this page

Trial

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

Title: Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
NCT number: NCT01552902
Status: Completed
Phases: Phase 4
Enrollment: 549 participants, actual
Lead sponsor: Shire
Conditions: Attention-deficit/Hyperactivity Disorder
Interventions: Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, Placebo
First posted: 2012-03-13
Last updated: 2021-06-10
Other registries' IDs: eudract:2011-005452-34
Results first posted: 2015-03-18

Source ClinicalTrials.gov

Registered outcomes5

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 Week 6	Baseline, Week 6	The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.
Secondary	Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Week 6	The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.
Other	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Baseline up to 3 days after last dose (last dose at Week 6)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Other	Change From Baseline in Blood Pressure at Week 6	Baseline, Week 6
Other	Change From Baseline in Pulse Rate at Week 6	Baseline, Week 6

Source ClinicalTrials.gov

Outcomes5

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 Week 6	Baseline, Week 6	Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Week 6	FAS.	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Baseline up to 3 days after last dose (last dose at Week 6)	Safety set.	participants	NUMBER
OTHER_PRE_SPECIFIED	Change From Baseline in Blood Pressure at Week 6	Baseline, Week 6	Safety set. Not all Safety set participants were evaluable for this outcome measure.	millimeter of mercury (mmHg)	MEAN
OTHER_PRE_SPECIFIED	Change From Baseline in Pulse Rate at Week 6	Baseline, Week 6	Safety set. Not all Safety set participants were evaluable for this outcome measure.	Beats per minute	MEAN

Source ClinicalTrials.gov

Results by group21

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 Week 6	Placebo		-17	Standard Error 1.03	units on a scale
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6	Lisdexamfetamine Dimesylate		-25.4	Standard Error 0.74	units on a scale
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6	Methylphenidate		-22.1	Standard Error 0.73	units on a scale
Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Placebo		50		percentage of participants
Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Lisdexamfetamine Dimesylate		81.4		percentage of participants
Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Methylphenidate		71.3		percentage of participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	Participants with TEAEs	49		participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Lisdexamfetamine Dimesylate	Participants with TEAEs	145		participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Methylphenidate	Participants with TEAEs	129		participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	Participants with serious TEAEs	1		participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	110
Overall Study	STARTED	Lisdexamfetamine Dimesylate	218
Overall Study	STARTED	Methylphenidate	219
Overall Study	COMPLETED	Placebo	97
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate	181
Overall Study	COMPLETED	Methylphenidate	186
Overall Study	NOT COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate	37
Overall Study	NOT COMPLETED	Methylphenidate	33

Source ClinicalTrials.gov

Adverse events36

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	Weight decreased	Investigations	Placebo	0	110	0
other	Weight decreased	Investigations	Lisdexamfetamine Dimesylate	23	218	23
other	Weight decreased	Investigations	Methylphenidate	11	219	11
other	Headache	Nervous system disorders	Placebo	9	110	13
other	Headache	Nervous system disorders	Lisdexamfetamine Dimesylate	33	218	45
other	Headache	Nervous system disorders	Methylphenidate	35	219	40
other	Dizziness	Nervous system disorders	Placebo	0	110	0
other	Dizziness	Nervous system disorders	Lisdexamfetamine Dimesylate	12	218	12
other	Dizziness	Nervous system disorders	Methylphenidate	11	219	11
other	Irritability	General disorders	Placebo	7	110	7

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Lisdexamfetamine Dimesylate
Total, all-cause mortality	Methylphenidate
Total, other adverse events	Placebo	32	110
Total, other adverse events	Lisdexamfetamine Dimesylate	113	218
Total, other adverse events	Methylphenidate	99	219
Total, serious adverse events	Placebo	1	110
Total, serious adverse events	Lisdexamfetamine Dimesylate	1	218
Total, serious adverse events	Methylphenidate	1	219

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28980198	DERIVED

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/NCT01552902

GET https://conductscience.org/api/trials/v1/NCT01552902/results?page=2

API reference For AI assistants