Trial · NCT01035255
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure
NCT01035255, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2015-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure. Trials, record NCT01035255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01035255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure
- NCT number
- NCT01035255
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 8,442 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- LCZ696 200 mg BID, Enalapril 10 mg BID
- First posted
- 2009-12-18
- Last updated
- 2016-08-15
- Results first posted
- 2015-09-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | up to 51 months | Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF. |
| Secondary | Number of Patients - All-cause Mortality | up to 51 months | Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014 |
| Secondary | Number of Patients Reported With Adjudicated Primary Causes of Death | up to 51 months | Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014 |
| Secondary | Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Baseline, Month 8 | Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Secondary | Number of Patients With First Confirmed Renal Dysfunction | up to 51 months | Number of patients with first confirmed renal dysfunction |
| Secondary | Percentage of Participants With New Onset of Atrial Fibrillation (AF) | up to 51 months | Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | up to 51 months | 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 | participants | NUMBER |
| SECONDARY | Number of Patients - All-cause Mortality | up to 51 months | 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 | participants | NUMBER |
| SECONDARY | Number of Patients Reported With Adjudicated Primary Causes of Death | up to 51 months | Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication. | participants | NUMBER |
| SECONDARY | Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Baseline, Month 8 | FAS included all randomized patients with two exclusions: 6 pts who did not qualify for randomization but were misrandomized into the study and did not receive study meds; 37 pts because they were randomized at sites that were closed due to serious GCP violations The analysis included all FAS patients with at least one KCCQ data up-to Month 8. | KCCQ Score | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With First Confirmed Renal Dysfunction | up to 51 months | 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 | participants | NUMBER |
| SECONDARY | Percentage of Participants With New Onset of Atrial Fibrillation (AF) | up to 51 months | The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis). | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | LCZ696 | Primary Composite | 914 | participants | |
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | Enalapril | Primary Composite | 1117 | participants | |
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | LCZ696 | CV death | 558 | participants | |
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | Enalapril | CV death | 693 | participants | |
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | LCZ696 | 1st HF Hospitalization | 537 | participants | |
| Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | Enalapril | 1st HF Hospitalization | 658 | participants | |
| Number of Patients - All-cause Mortality | LCZ696 | 711 | participants | ||
| Number of Patients - All-cause Mortality | Enalapril | 835 | participants | ||
| Number of Patients Reported With Adjudicated Primary Causes of Death | LCZ696 | Number of patients who died | 714 | participants | |
| Number of Patients Reported With Adjudicated Primary Causes of Death | Enalapril | Number of patients who died | 837 | participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 | 4,209 | |
| Overall Study | STARTED | Enalapril | 4,233 | |
| Overall Study | GCP Violations | LCZ696 | 18 | |
| Overall Study | GCP Violations | Enalapril | 19 | |
| Overall Study | Mis-randomized | LCZ696 | 4 | |
| Overall Study | Mis-randomized | Enalapril | 2 | |
| Overall Study | Full Analysis Set (FAS) | LCZ696 | 4,187 | |
| Overall Study | Full Analysis Set (FAS) | Enalapril | 4,212 | |
| Overall Study | COMPLETED | LCZ696 | 3,468 | |
| Overall Study | COMPLETED | Enalapril | 3,371 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,416
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LCZ696 | 140 | 4,203 | |
| other | Anaemia | Blood and lymphatic system disorders | Enalapril | 160 | 4,229 | |
| other | Angina pectoris | Cardiac disorders | LCZ696 | 125 | 4,203 | |
| other | Angina pectoris | Cardiac disorders | Enalapril | 125 | 4,229 | |
| other | Atrial fibrillation | Cardiac disorders | LCZ696 | 159 | 4,203 | |
| other | Atrial fibrillation | Cardiac disorders | Enalapril | 137 | 4,229 | |
| other | Cardiac failure | Cardiac disorders | LCZ696 | 214 | 4,203 | |
| other | Cardiac failure | Cardiac disorders | Enalapril | 274 | 4,229 | |
| other | Constipation | Gastrointestinal disorders | LCZ696 | 85 | 4,203 | |
| other | Constipation | Gastrointestinal disorders | Enalapril | 120 | 4,229 |
1 to 10 of 2,416Source ClinicalTrials.gov
See all 2,416 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 | ||
| Total, all-cause mortality | Enalapril | ||
| Total, other adverse events | LCZ696 | 2,479 | 4,203 |
| Total, other adverse events | Enalapril | 2,594 | 4,229 |
| Total, serious adverse events | LCZ696 | 1,937 | 4,203 |
| Total, serious adverse events | Enalapril | 2,142 | 4,229 |
Source ClinicalTrials.gov
Papers52
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LCZ696 vs Enalapril: Number of Patients With First Confirmed Renal Dysfunction | Trial comparisons |
| LCZ696 vs Enalapril: Number of Patients - All-cause Mortality | Trial comparisons |
| LCZ696 vs Enalapril: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01035255
GET https://conductscience.org/api/trials/v1/NCT01035255/results?page=2