Trial · NCT00500071
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
NCT00500071, Phase 4, Completed, Shire; results first posted 2009-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD. Trials, record NCT00500071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500071
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
- NCT number
- NCT00500071
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 318 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Vyvanse (lisdexamfetamine dimesylate)
- First posted
- 2007-07-12
- Last updated
- 2022-03-10
- Results first posted
- 2009-09-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks | Baseline and 7 weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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 | Weekly Change From Baseline in Total ADHD-RS-IV Score | Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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) | 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 or 2 on the scale. |
| Secondary | Number of Participants With Improvement onParent Global Assessment (PGA) | 7 weeks | Parent Global Assessment (PGA) 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 Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks | Baseline and 7 weeks | Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes. |
| Secondary | Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks | Baseline and 7 weeks | Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Weekly Change From Baseline in Total ADHD-RS-IV Score | Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks | ITT | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks | Baseline and 7 weeks | Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | 7 weeks | ITT | Participants | NUMBER |
| SECONDARY | Number of Participants With Improvement onParent Global Assessment (PGA) | 7 weeks | ITT | Participants | NUMBER |
| SECONDARY | Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks | Baseline and 7 weeks | ITT | Units on a scale | MEAN |
| SECONDARY | Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks | Baseline and 7 weeks | ITT | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 1 | -11.3 | Standard Error 0.62 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 2 | -17.8 | Standard Error 0.63 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 3 | -21.7 | Standard Error 0.61 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 4 | -25.4 | Standard Error 0.61 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 5 | -27.0 | Standard Error 0.60 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 6 | -28.9 | Standard Error 0.60 | Units on a scale |
| Weekly Change From Baseline in Total ADHD-RS-IV Score | Vyvanse | Week 7 | -29.8 | Standard Error 0.58 | Units on a scale |
| Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks | Vyvanse | -28.6 | Standard Error 0.61 | Units on a scale | |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) | Vyvanse | 284 | Participants | ||
| Number of Participants With Improvement onParent Global Assessment (PGA) | Vyvanse | 267 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening and Washout Phase | STARTED | Vyvanse | 318 | |
| Screening and Washout Phase | COMPLETED | Vyvanse | 317 | |
| Screening and Washout Phase | NOT COMPLETED | Vyvanse | 1 | |
| Dose-optimization and Maintenance Phase | STARTED | Vyvanse | 317 | |
| Dose-optimization and Maintenance Phase | COMPLETED | Vyvanse | 295 | |
| Dose-optimization and Maintenance Phase | NOT COMPLETED | Vyvanse | 22 | |
| 30-day Safety Follow-up | STARTED | Vyvanse | 295 | |
| 30-day Safety Follow-up | COMPLETED | Vyvanse | 278 | |
| 30-day Safety Follow-up | NOT COMPLETED | Vyvanse | 17 |
Source ClinicalTrials.gov
Adverse events12
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 upper | Gastrointestinal disorders | Vyvanse | 42 | 317 | |
| other | Nausea | Gastrointestinal disorders | Vyvanse | 17 | 317 | |
| other | Vomiting | Gastrointestinal disorders | Vyvanse | 17 | 317 | |
| other | Irritability | General disorders | Vyvanse | 51 | 317 | |
| other | Weight decreased | Investigations | Vyvanse | 54 | 317 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Vyvanse | 137 | 317 | |
| other | Headache | Nervous system disorders | Vyvanse | 44 | 317 | |
| other | Affect liability | Psychiatric disorders | Vyvanse | 23 | 317 | |
| other | Initial insomnia | Nervous system disorders | Vyvanse | 36 | 317 | |
| other | Insomnia | Nervous system disorders | Vyvanse | 51 | 317 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vyvanse | ||
| Total, other adverse events | Vyvanse | 269 | 317 |
| Total, serious adverse events | Vyvanse | 2 | 317 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00500071
GET https://conductscience.org/api/trials/v1/NCT00500071/registered