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Comparison · NCT00645099-8a7a48a3

Paliperidone ER vs Olanzapine: Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up

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. Paliperidone ER vs Olanzapine: Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up. Trial comparisons, record NCT00645099-8a7a48a3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00645099-8a7a48a3

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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 10.1320.08970.191wilson
Risk in group 20.2330.1750.304wilson
Risk difference, group 1 minus group 2-0.101-0.183-0.0185newcombe hybrid score
Risk ratio, group 1 over group 20.5670.3540.909log
Odds ratio, group 1 over group 20.5010.2840.886log
Number needed to treat, for one fewer participant with the outcome on Paliperidone ER than on Olanzapine9.915.4554.2from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Paliperidone ER6-mg or 9-mg tablet once daily flexible dosing for 6 months23174OG000
Group 2Olanzapine10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months38163OG001

Outcome

Type
SECONDARY
Title
Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up
Description
Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on~Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:~* waist circumference men \> 102 cm; waist circumference women \> 88 cm~* TG ≥ 150 mg/dL~* HDL cholesterol men \<40 mg/dL; HDL cholesterol women \<50 mg/dL~* Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg~* Fasting glucose ≥ 110 mg /dL
Time frame
6 months
Population
The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline.

Source ClinicalTrials.gov

Trial

Title
A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
NCT number
NCT00645099
Phases
PHASE3
Conditions
Schizophrenia
Interventions
olanzapine, paliperidone ER
Lead sponsor
Janssen-Cilag International NV
Results first posted
2010-07-29

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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