Comparison · NCT03467152-e664af1f
Irsenontrine 50 mg vs Placebo: Number of Participants With Orthostatic Tachycardia
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Irsenontrine 50 mg vs Placebo: Number of Participants With Orthostatic Tachycardia. Trial comparisons, record NCT03467152-e664af1f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03467152-e664af1f
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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 | 0 | 0.0374 | wilson | |
| Risk in group 2 | 0.0103 | 0.00182 | 0.0561 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0103 | -0.0561 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Irsenontrine 50 mg than on Placebo | 97 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Irsenontrine 50 mg | Participants received Irsenontrine 50 milligram (mg), capsule, once daily for 12 weeks. | 0 | 99 | OG001 |
| Group 2 | Placebo | Participants received Irsenontrine-matched placebo capsule, orally, once daily for 12 weeks. | 1 | 97 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Orthostatic Tachycardia
- Description
Orthostatic tachycardia by numerical criteria was defined by the following numerical criteria: Standing heart rate (HR) increased by \>30 beats/min compared to supine and absolute standing HR was \>100 beats/min.
- Time frame
- From first dose of study drug up to Week 16
- Population
- The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment.
Source ClinicalTrials.gov
Trial
- Title
- Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
- NCT number
- NCT03467152
- Phases
- PHASE2
- Conditions
- Dementia With Lewy Bodies
- Interventions
- Irsenontrine, Placebo
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2022-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03467152?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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