Comparison · NCT03443063-55c26991
Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values
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. Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values. Trial comparisons, record NCT03443063-55c26991. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03443063-55c26991
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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 | 0.324 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.324 | 0.324 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lemborexant: Severe Renal Impairment | Participants with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m\^2 and not on dialysis) received a single dose of 10 mg lemborexant (oral tablet) in the morning after an overnight fast. | 0 | 8 | OG000 |
| Group 2 | Lemborexant: Normal Renal Function | Participants with normal renal function (eGFR \>=90 mL/min/1.73 m\^2) demographically matched to participants with severe renal impairment (matched according to age, race, sex, and BMI) received a single dose of 10 mg lemborexant (oral tablet) on Day 1 in the morning after an overnight fast. | 0 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values
- Description
- Time frame
- Up to Day 11
- Population
- The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
- NCT number
- NCT03443063
- Phases
- PHASE1
- Conditions
- Renal Impairment
- Interventions
- Lemborexant
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2020-01-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03443063?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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