Trial · NCT00500149
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
NCT00500149, Phase 3, Completed, Shire; results first posted 2009-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00500149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500149
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT00500149
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 129 participants, actual
- Lead sponsor
- Shire
- Conditions
- ADHD
- Interventions
- Vyvanse (lisdexamfetamine dimesylate), Placebo
- First posted
- 2007-07-12
- Last updated
- 2021-06-14
- Results first posted
- 2009-06-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Onset of Effect of Vyvanse | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. | The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal). |
| Secondary | Duration of Effect of Vyvanse | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. | Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Onset of Effect of Vyvanse | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. | Analysis on the intention-to-treat (ITT) population. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Effect of Vyvanse | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. | Analysis on intention-to-treat (ITT) population. | scores on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Onset of Effect of Vyvanse | Vyvanse | 1.5 hours | 0.70 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Placebo | 1.5 hours | 1.14 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Vyvanse | 2.5 hours | 0.45 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Placebo | 2.5 hours | 1.42 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Vyvanse | 5 hours | 0.44 | Standard Error 0.10 | scores on a scale |
| Onset of Effect of Vyvanse | Placebo | 5 hours | 1.60 | Standard Error 0.10 | scores on a scale |
| Onset of Effect of Vyvanse | Vyvanse | 7.5 hours | 0.54 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Placebo | 7.5 hours | 1.56 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Vyvanse | 10 hours | 0.60 | Standard Error 0.09 | scores on a scale |
| Onset of Effect of Vyvanse | Placebo | 10 hours | 1.43 | Standard Error 0.09 | scores on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled (Dose-optimization Phase) | STARTED | Vyvanse First | 129 | |
| Enrolled (Dose-optimization Phase) | STARTED | Placebo First | 0 | |
| Enrolled (Dose-optimization Phase) | COMPLETED | Vyvanse First | 117 | |
| Enrolled (Dose-optimization Phase) | COMPLETED | Placebo First | 0 | |
| Enrolled (Dose-optimization Phase) | NOT COMPLETED | Vyvanse First | 12 | |
| Enrolled (Dose-optimization Phase) | NOT COMPLETED | Placebo First | 0 | |
| First Intervention (Cross-over Phase) | STARTED | Vyvanse First | 58 | |
| First Intervention (Cross-over Phase) | STARTED | Placebo First | 59 | |
| First Intervention (Cross-over Phase) | COMPLETED | Vyvanse First | 56 | |
| First Intervention (Cross-over Phase) | COMPLETED | Placebo First | 57 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
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 | Decreased Appetite | Metabolism and nutrition disorders | Vyvanse | 7 | 115 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Placebo | 1 | 115 | |
| other | Headache | Nervous system disorders | Vyvanse | 6 | 115 | |
| other | Headache | Nervous system disorders | Placebo | 2 | 115 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vyvanse | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vyvanse | 13 | 115 |
| Total, other adverse events | Placebo | 3 | 115 |
| Total, serious adverse events | Vyvanse | 0 | 115 |
| Total, serious adverse events | Placebo | 0 | 115 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vyvanse 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.
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/NCT00500149
GET https://conductscience.org/api/trials/v1/NCT00500149/results?page=2