Pemafibrate vs Placebo: Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, 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 | 0.113 | 0.104 | 0.121 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.108 | 0.1 | 0.117 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00417 | -0.00783 | 0.0162 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.932 | 1.16 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.923 | 1.18 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Pemafibrate than on Placebo | 240 | 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. | 590 | 5,240 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants receiving Placebo matching tablet twice daily. | 570 | 5,257 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death) | ClinicalTrials.gov |
| Description | Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events. | ClinicalTrials.gov |
| Time frame | From Baseline to a Median of 3.3 Years | ClinicalTrials.gov |
| Population | Intention to treat population (ITT) | 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.