Pemafibrate vs Placebo: Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death)
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 | 0.0853 | 0.078 | 0.0932 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0812 | 0.0741 | 0.0889 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00408 | -0.0065 | 0.0147 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.925 | 1.19 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.918 | 1.21 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Pemafibrate than on Placebo | 245 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Pemafibrate | Participants receiving K-877 tablets administered twice daily. | 447 | 5,240 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants receiving Placebo matching tablet twice daily. | 427 | 5,257 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death) | ClinicalTrials.gov |
| Description | The 4-component composite secondary endpoints events are nonfatal myocardial infarction, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or cardiovascular death | ClinicalTrials.gov |
| Time frame | From Baseline to a Median of 3.3 Years | ClinicalTrials.gov |
| Population | ITT population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) | ClinicalTrials.gov |
| NCT number | NCT03071692 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Type2 Diabetes, Dyslipidemia | ClinicalTrials.gov |
| Interventions | K-877, Placebo | ClinicalTrials.gov |
| Lead sponsor | Kowa Research Institute, Inc. | ClinicalTrials.gov |
| Results first posted | 2025-09-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03071692?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.