Trial · NCT00764868
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
NCT00764868, Phase 3, Completed, Shire; results first posted 2011-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study. Trials, record NCT00764868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00764868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
- NCT number
- NCT00764868
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 269 participants, actual
- Lead sponsor
- Shire
- Conditions
- ADHD
- Interventions
- Lisdexamfetamine Dimesylate (LDX)
- First posted
- 2008-10-02
- Last updated
- 2021-06-14
- Results first posted
- 2011-03-28
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 (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks | Baseline and up to 52 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 | Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | up to 52 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 | Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks | Baseline and Up to 52 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 (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks | Baseline and up to 52 weeks | Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure. | Units on a scale | MEAN |
| SECONDARY | Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | up to 52 weeks | FAS | Percent of participants | NUMBER |
| SECONDARY | Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks | Baseline and Up to 52 weeks | FAS | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks | Lisdexamfetamine Dimesylate (LDX) | -26.2 | Standard Deviation 9.75 | Units on a scale | |
| Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | Lisdexamfetamine Dimesylate (LDX) | 87.2 | Percent of participants | ||
| Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks | Lisdexamfetamine Dimesylate (LDX) | 3.9 | Standard Deviation 9.73 | Units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lisdexamfetamine Dimesylate (LDX) | 269 | |
| Overall Study | COMPLETED | Lisdexamfetamine Dimesylate (LDX) | 156 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine Dimesylate (LDX) | 113 |
Source ClinicalTrials.gov
Adverse events21
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 | Dry Mouth | Gastrointestinal disorders | Lisdexamfetamine Dimesylate (LDX) | 14 | 265 | 15 |
| other | Irritability | General disorders | Lisdexamfetamine Dimesylate (LDX) | 33 | 265 | 36 |
| other | Influenza | Infections and infestations | Lisdexamfetamine Dimesylate (LDX) | 18 | 265 | 18 |
| other | Nasopharyngitis | Infections and infestations | Lisdexamfetamine Dimesylate (LDX) | 19 | 265 | 26 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Lisdexamfetamine Dimesylate (LDX) | 58 | 265 | 74 |
| other | Weight Decreased | Investigations | Lisdexamfetamine Dimesylate (LDX) | 43 | 265 | 46 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (LDX) | 56 | 265 | 71 |
| other | Dizziness | Nervous system disorders | Lisdexamfetamine Dimesylate (LDX) | 14 | 265 | 16 |
| other | Headache | Nervous system disorders | Lisdexamfetamine Dimesylate (LDX) | 55 | 265 | 81 |
| other | Insomnia | Psychiatric disorders | Lisdexamfetamine Dimesylate (LDX) | 32 | 265 | 43 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (LDX) | ||
| Total, other adverse events | Lisdexamfetamine Dimesylate (LDX) | 230 | 265 |
| Total, serious adverse events | Lisdexamfetamine Dimesylate (LDX) | 10 | 265 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23410138 | 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.
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/NCT00764868
GET https://conductscience.org/api/trials/v1/NCT00764868/events?page=2