Trial · NCT01328756
Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT01328756, Phase 4, Completed, Shire; results first posted 2015-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT01328756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01328756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT01328756
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 314 participants, actual
- Lead sponsor
- Shire
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Lisdexamfetamine dimesylate
- First posted
- 2011-04-05
- Last updated
- 2021-06-10
- Other registries' IDs
- eudract:2010-020951-30
- Results first posted
- 2015-08-06
- Limitations and caveats
- Since this study is an open-label trial, results should be interpreted with caution.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 3 days after the last dose of study treatment (up to 2 years) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment. |
| Primary | Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in Height at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | BMI was calculated as (weight \[kilogram\] per height \[square meter\]). |
| Primary | Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | |
| Primary | Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 3 days after the last dose of study treatment (up to 2 years) | Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study. | participants | NUMBER |
| PRIMARY | Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | beats per minute | MEAN |
| PRIMARY | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | mmHg | MEAN |
| PRIMARY | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | mmHg | MEAN |
| PRIMARY | Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | kilogram(s) | MEAN |
| PRIMARY | Change From Baseline in Height at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | centimeter(s) | MEAN |
| PRIMARY | Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | kilogram per square meter | MEAN |
| PRIMARY | Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | beats per minute | MEAN |
| PRIMARY | Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | milliseconds | MEAN |
| PRIMARY | Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | milliseconds | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Lisdexamfetamine Dimesylate | Any TEAE | 282 | participants | |
| Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Lisdexamfetamine Dimesylate | Serious TEAE | 28 | participants | |
| Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 7 | Standard Deviation 11.6 | beats per minute | |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 3.2 | Standard Deviation 9.05 | mmHg | |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 3.4 | Standard Deviation 10.33 | mmHg | |
| Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 2.1 | Standard Deviation 5.83 | kilogram(s) | |
| Change From Baseline in Height at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 6.1 | Standard Deviation 4.9 | centimeter(s) | |
| Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | -0.5 | Standard Deviation 1.72 | kilogram per square meter | |
| Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | 7.1 | Standard Deviation 13.51 | beats per minute | |
| Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA) | Lisdexamfetamine Dimesylate | -10.3 | Standard Deviation 23.53 | milliseconds |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lisdexamfetamine Dimesylate | 314 | |
| Overall Study | COMPLETED | Lisdexamfetamine Dimesylate | 191 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine Dimesylate | 123 |
Source ClinicalTrials.gov
Adverse events45
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 | Gastrointestinal disorders | Lisdexamfetamine Dimesylate | 29 | 314 | 37 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lisdexamfetamine Dimesylate | 28 | 314 | 34 |
| other | Nausea | Gastrointestinal disorders | Lisdexamfetamine Dimesylate | 31 | 314 | 41 |
| other | Vomiting | Gastrointestinal disorders | Lisdexamfetamine Dimesylate | 27 | 314 | 33 |
| other | Irritability | General disorders | Lisdexamfetamine Dimesylate | 36 | 314 | 39 |
| other | Pyrexia | General disorders | Lisdexamfetamine Dimesylate | 31 | 314 | 40 |
| other | Gastroenteritis | Infections and infestations | Lisdexamfetamine Dimesylate | 18 | 314 | 21 |
| other | Nasopharyngitis | Infections and infestations | Lisdexamfetamine Dimesylate | 73 | 314 | 129 |
| other | Pharyngitis | Infections and infestations | Lisdexamfetamine Dimesylate | 16 | 314 | 18 |
| other | Weight decreased | Investigations | Lisdexamfetamine Dimesylate | 63 | 314 | 68 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisdexamfetamine Dimesylate | ||
| Total, other adverse events | Lisdexamfetamine Dimesylate | 250 | 314 |
| Total, serious adverse events | Lisdexamfetamine Dimesylate | 28 | 314 |
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/NCT01328756
GET https://conductscience.org/api/trials/v1/NCT01328756/results?page=2