Trial · NCT01328756
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| PRIMARY | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Safety population with participants evaluable for this outcome | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment. | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | LOTA (Week 104) | FAS population | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | LOTA (Week 104) | FAS population | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01328756/outcomes