Trial · NCT00877487

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

NCT00877487, Phase 4, Completed, Shire; results first posted 2011-08-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder. Trials, record NCT00877487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00877487

On this page

Trial

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

Title: Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
NCT number: NCT00877487
Status: Completed
Phases: Phase 4
Enrollment: 123 participants, actual
Lead sponsor: Shire
Conditions: Attention-Deficit/Hyperactivity Disorder
Interventions: SPD489 (Lisdexamfetamine dimesylate), Placebo
First posted: 2009-04-07
Last updated: 2021-06-22
Results first posted: 2011-08-02

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percent of Treatment Failures at up to 6 Weeks	Up to 6 weeks	Treatment failure defined as \> or equal to 50% increase in the ADHD-RS with adult prompts total score and a \> or equal to 2 point increase in the CGI-S score.
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks	Up to 6 weeks	The ADHD-RS 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	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Up to 6 weeks	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks	Up to 6 weeks	FAS	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Up to 6 weeks	FAS	Percent of Participants	NUMBER
PRIMARY	Percent of Treatment Failures at up to 6 Weeks	Up to 6 weeks	Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.	Percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group18

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 (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks	SPD489		1.6	Standard Error 1.39	Units on a scale
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks	Placebo		16.8	Standard Error 1.35	Units on a scale
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	SPD489	Normal, not at all ill	32.1		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Placebo	Normal, not at all ill	5.0		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	SPD489	Borderline mentally ill	35.7		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Placebo	Borderline mentally ill	11.7		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	SPD489	Mildly ill	17.9		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Placebo	Mildly ill	11.7		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	SPD489	Moderately ill	7.1		Percent of Participants
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks	Placebo	Moderately ill	33.3		Percent of Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Open-label Treatment Phase	STARTED	SPD489	123
Open-label Treatment Phase	STARTED	Placebo	0
Open-label Treatment Phase	COMPLETED	SPD489	116
Open-label Treatment Phase	COMPLETED	Placebo	0
Open-label Treatment Phase	NOT COMPLETED	SPD489	7
Open-label Treatment Phase	NOT COMPLETED	Placebo	0
Double-blind Randomized Withdrawal Phase	STARTED	SPD489	56
Double-blind Randomized Withdrawal Phase	STARTED	Placebo	60
Double-blind Randomized Withdrawal Phase	COMPLETED	SPD489	50
Double-blind Randomized Withdrawal Phase	COMPLETED	Placebo	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

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	Headache	Nervous system disorders	SPD489	8	56	8
other	Headache	Nervous system disorders	Placebo	3	60	3
other	Insomnia	Psychiatric disorders	SPD489	3	56	3
other	Insomnia	Psychiatric disorders	Placebo	3	60	3
other	Upper respiratory tract infection	Infections and infestations	SPD489	5	56	5
other	Upper respiratory tract infection	Infections and infestations	Placebo	0	60	0
serious	Suicidal ideation	Psychiatric disorders	SPD489	0	56	0
serious	Suicidal ideation	Psychiatric disorders	Placebo	1	60	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SPD489
Total, all-cause mortality	Placebo
Total, other adverse events	SPD489	16	56
Total, other adverse events	Placebo	6	60
Total, serious adverse events	SPD489	0	56
Total, serious adverse events	Placebo	1	60

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22780921	RESULT	PubMed
25295648	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
SPD489 vs Placebo: 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.

GET https://conductscience.org/api/trials/v1/NCT00877487

GET https://conductscience.org/api/trials/v1/NCT00877487/registered

API reference For AI assistants