Trial · NCT01552915
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
NCT01552915, Phase 4, Completed, Shire; results first posted 2014-12-11
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 NCT01552915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01552915
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
- NCT01552915
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 464 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Interventions
- Lisdexamfetamine dimesylate, Methylphenidate Hydrochloride, Placebo
- First posted
- 2012-03-13
- Last updated
- 2021-06-08
- Results first posted
- 2014-12-11
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 8 | Baseline and week 8 | 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. Higher score indicates more severe symptoms. |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) | Week 8 | 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 in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 Weeks | |
| Secondary | Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks | |
| Secondary | Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks |
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 8 | Baseline and week 8 | Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) | Week 8 | Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 Weeks | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment | Baseline and up to 8 weeks | Safety Set: All randomized subjects who took at least 1 dose of investigational product. | bpm | MEAN |
Source ClinicalTrials.gov
Results by group15
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 8 | Placebo | -13.4 | Standard Error 1.19 | units on a scale | |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 | SPD489 | -25.6 | Standard Error 0.82 | units on a scale | |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 | OROS-MPH | -23.5 | Standard Error 0.80 | units on a scale | |
| Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) | Placebo | 34.8 | percentage of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) | SPD489 | 83.1 | percentage of participants | ||
| Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) | OROS-MPH | 81.0 | percentage of participants | ||
| Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Placebo | -0.8 | Standard Deviation 8.97 | mmHg | |
| Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | SPD489 | 2.4 | Standard Deviation 9.46 | mmHg | |
| Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | OROS-MPH | 0.4 | Standard Deviation 9.90 | mmHg | |
| Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment | Placebo | -1.2 | Standard Deviation 8.11 | mmHg |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 91 | |
| Overall Study | STARTED | SPD489 | 184 | |
| Overall Study | STARTED | OROS-MPH | 184 | |
| Overall Study | COMPLETED | Placebo | 68 | |
| Overall Study | COMPLETED | SPD489 | 155 | |
| Overall Study | COMPLETED | OROS-MPH | 157 | |
| Overall Study | NOT COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | SPD489 | 29 | |
| Overall Study | NOT COMPLETED | OROS-MPH | 27 |
Source ClinicalTrials.gov
Adverse events51
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 | Placebo | 4 | 91 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD489 | 12 | 184 | 12 |
| other | Abdominal pain upper | Gastrointestinal disorders | OROS-MPH | 10 | 184 | 13 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 91 | 1 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 | 15 | 184 | 17 |
| other | Dry mouth | Gastrointestinal disorders | OROS-MPH | 11 | 184 | 11 |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 91 | 4 |
| other | Nausea | Gastrointestinal disorders | SPD489 | 14 | 184 | 14 |
| other | Nausea | Gastrointestinal disorders | OROS-MPH | 15 | 184 | 17 |
| other | Fatigue | General disorders | Placebo | 3 | 91 | 3 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | SPD489 | ||
| Total, all-cause mortality | OROS-MPH | ||
| Total, other adverse events | Placebo | 39 | 91 |
| Total, other adverse events | SPD489 | 139 | 184 |
| Total, other adverse events | OROS-MPH | 120 | 184 |
| Total, serious adverse events | Placebo | 0 | 91 |
| Total, serious adverse events | SPD489 | 1 | 184 |
| Total, serious adverse events | OROS-MPH | 1 | 184 |
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.
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/NCT01552915
GET https://conductscience.org/api/trials/v1/NCT01552915/events?page=2