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Comparison · NCT00845026-838efbbb

LY2140023 vs Standard-of-Care (SOC): Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)

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. LY2140023 vs Standard-of-Care (SOC): Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs). Trial comparisons, record NCT00845026-838efbbb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00845026-838efbbb

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.02540.008680.0721wilson
Risk in group 20.03150.01230.0782wilson
Risk difference, group 1 minus group 2-0.00607-0.05570.0444newcombe hybrid score
Risk ratio, group 1 over group 20.8070.1853.53log
Odds ratio, group 1 over group 20.8020.1763.66log
Number needed to treat, for one fewer participant with the outcome on LY2140023 than on Standard-of-Care (SOC)165from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1LY214002380 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.3118OG000
Group 2Standard-of-Care (SOC)
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).~olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).~risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
4127OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)
Description
A potentially clinically significant QT interval (high) is defined as a value meeting the criteria of (\> 450 millisecond \[ms\]) at anytime during the active treatment phase, provided it does not meet the criteria at baseline.~(analysis for Study Period III only)
Time frame
Baseline through 24 weeks
Population
All randomized participants with normal baseline measurement and at least one post-baseline measurement.

Source ClinicalTrials.gov

Trial

Title
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
NCT number
NCT00845026
Phases
PHASE2
Conditions
Schizophrenia
Interventions
LY2140023, aripiprazole, olanzapine, risperidone
Lead sponsor
Denovo Biopharma LLC
Results first posted
2022-09-01

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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