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Comparison · NCT00120289-13dc40ff

ERN + Simvastatin vs Placebo + Simvastatin: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization

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. ERN + Simvastatin vs Placebo + Simvastatin: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization. Trial comparisons, record NCT00120289-13dc40ff. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00120289-13dc40ff

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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 10.1640.1470.182wilson
Risk in group 20.1620.1450.18wilson
Risk difference, group 1 minus group 20.00259-0.02220.0274newcombe hybrid score
Risk ratio, group 1 over group 21.020.8731.18log
Odds ratio, group 1 over group 21.020.851.22log
Number needed to treat, for one more participant with the outcome on ERN + Simvastatin than on Placebo + Simvastatin386from 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 1ERN + Simvastatin
Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
2821,718OG000
Group 2Placebo + SimvastatinSimvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target2741,696OG001

Outcome

Type
PRIMARY
Title
Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization
Description
Time frame
Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.
Population
Intention-to-treat

Source ClinicalTrials.gov

Trial

Title
Niacin Plus Statin to Prevent Vascular Events
NCT number
NCT00120289
Phases
PHASE3
Conditions
Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Atherosclerosis, Myocardial Infarction
Interventions
Extended release niacin, Simvastatin
Lead sponsor
Axio Research. LLC
Results first posted
2015-06-17

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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