LCZ696 vs Enalapril: Number of Patients With First Confirmed Renal Dysfunction
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 | 0.0225 | 0.0184 | 0.0274 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0256 | 0.0213 | 0.0309 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00319 | -0.00981 | 0.0034 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.876 | 0.666 | 1.15 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.873 | 0.66 | 1.15 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on LCZ696 than on Enalapril | 313 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | LCZ696 | single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period | 94 | 4,187 | OG000 | ClinicalTrials.gov |
| Group 2 | Enalapril | single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period | 108 | 4,212 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Patients With First Confirmed Renal Dysfunction | ClinicalTrials.gov |
| Description | Number of patients with first confirmed renal dysfunction | ClinicalTrials.gov |
| Time frame | up to 51 months | ClinicalTrials.gov |
| Population | Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure | ClinicalTrials.gov |
| NCT number | NCT01035255 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Heart Failure With Reduced Ejection Fraction | ClinicalTrials.gov |
| Interventions | LCZ696 200 mg BID, Enalapril 10 mg BID | ClinicalTrials.gov |
| Lead sponsor | Novartis Pharmaceuticals | ClinicalTrials.gov |
| Results first posted | 2015-09-07 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01035255?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.