Comparison · NCT00697515-c7bfff7a
SPD489 vs Placebo: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. SPD489 vs Placebo: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase. Trial comparisons, record NCT00697515-c7bfff7a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00697515-c7bfff7a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.68 | 0.584 | 0.762 | wilson | |
| Risk in group 2 | 0.126 | 0.0753 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | 0.553 | 0.43 | 0.65 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.38 | 3.18 | 9.1 | log | |
| Odds ratio, group 1 over group 2 | 14.7 | 7.19 | 30 | log | |
| Number needed to treat, for one more participant with the outcome on SPD489 than on Placebo | 1.81 | 1.54 | 2.32 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SPD489 | Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg | 70 | 103 | OG000 |
| Group 2 | Placebo | Placebo is administered once-daily | 13 | 103 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase
- Description
- 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.
- Time frame
- 7 days
- Population
- ITT
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT00697515
- Phases
- PHASE3
- Conditions
- ADHD
- Interventions
- LDX, Placebo
- Lead sponsor
- Shire
- Results first posted
- 2010-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00697515?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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