Simvastatin Plus Ezetimibe vs Placebo: Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.152 | 0.142 | 0.164 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.179 | 0.167 | 0.191 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0263 | -0.0422 | -0.0104 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.853 | 0.774 | 0.939 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.826 | 0.736 | 0.927 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Simvastatin Plus Ezetimibe than on Placebo | 38 | 23.7 | 96.1 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Simvastatin Plus Ezetimibe | A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet). | 639 | 4,193 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet). | 749 | 4,191 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome) | ClinicalTrials.gov |
| Description | Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events. | ClinicalTrials.gov |
| Time frame | Median follow-up 4.9 years | ClinicalTrials.gov |
| Population | Includes only those patients initially randomized to simvastatin plus ezetimibe versus placebo (as opposed to all patients ever randomized to simvastatin plus ezetimibe versus all patients allocated placebo) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study of Heart and Renal Protection | ClinicalTrials.gov |
| NCT number | NCT00125593 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Kidney Disease, Chronic | ClinicalTrials.gov |
| Interventions | Simvastatin 20 mg, Ezetimibe 10mg, Placebo | ClinicalTrials.gov |
| Lead sponsor | University of Oxford | ClinicalTrials.gov |
| Results first posted | 2012-02-01 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00125593?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.