Trial · NCT00853658
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
NCT00853658, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure. Trials, record NCT00853658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
- NCT number
- NCT00853658
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,064 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Heart Failure
- Interventions
- Enalapril, Aliskiren
- First posted
- 2009-03-02
- Last updated
- 2016-11-25
- Other registries' IDs
- eudract:2008-004104-31
- Results first posted
- 2016-11-25
Source ClinicalTrials.gov
Registered outcomes3
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 End of Study (78 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 | Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Baseline, Month 12 | Change from baseline to Month 12 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 | All Cause Death | up to end of study (78 months) | Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event. |
Source ClinicalTrials.gov
Outcomes3
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 End of Study (78 months) | Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations. | participants | NUMBER |
| SECONDARY | Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Baseline, Month 12 | Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations. | KCCQ Score | LEAST_SQUARES_MEAN |
| SECONDARY | All Cause Death | up to end of study (78 months) | Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
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 | Combination Aliskiren / Enalapril | Primary Composite | 770 | 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 | Aliskiren | Primary Composite | 791 | 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 | 808 | 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 | Combination Aliskiren / Enalapril | CV death | 512 | 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 | Aliskiren | CV death | 562 | 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 | 547 | 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 | Combination Aliskiren / Enalapril | 1st HF Hospitalization | 430 | 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 | Aliskiren | 1st HF Hospitalization | 442 | 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 | 452 | participants | |
| Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | Combination Aliskiren / Enalapril | -5.04 | Standard Error 0.56 | KCCQ Score |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Aliskiren / Enalapril | 2,354 | |
| Overall Study | STARTED | Aliskiren | 2,356 | |
| Overall Study | STARTED | Enalapril | 2,354 | |
| Overall Study | Full Analysis Set (FAS) | Combination Aliskiren / Enalapril | 2,340 | |
| Overall Study | Full Analysis Set (FAS) | Aliskiren | 2,340 | |
| Overall Study | Full Analysis Set (FAS) | Enalapril | 2,336 | |
| Overall Study | Safety Set | Combination Aliskiren / Enalapril | 2,347 | |
| Overall Study | Safety Set | Aliskiren | 2,348 | |
| Overall Study | Safety Set | Enalapril | 2,345 | |
| Overall Study | COMPLETED | Combination Aliskiren / Enalapril | 1,567 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events4,146
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 | Combination of Aliskiren and Enalapril | 124 | 2,347 | |
| other | Anaemia | Blood and lymphatic system disorders | Aliskiren | 115 | 2,348 | |
| other | Anaemia | Blood and lymphatic system disorders | Enalapril | 111 | 2,345 | |
| other | Angina pectoris | Cardiac disorders | Combination of Aliskiren and Enalapril | 81 | 2,347 | |
| other | Angina pectoris | Cardiac disorders | Aliskiren | 86 | 2,348 | |
| other | Angina pectoris | Cardiac disorders | Enalapril | 71 | 2,345 | |
| other | Atrial fibrillation | Cardiac disorders | Combination of Aliskiren and Enalapril | 199 | 2,347 | |
| other | Atrial fibrillation | Cardiac disorders | Aliskiren | 238 | 2,348 | |
| other | Atrial fibrillation | Cardiac disorders | Enalapril | 184 | 2,345 | |
| other | Cardiac failure | Cardiac disorders | Combination of Aliskiren and Enalapril | 241 | 2,347 |
1 to 10 of 4,146Source ClinicalTrials.gov
See all 4,146 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination of Aliskiren and Enalapril | ||
| Total, all-cause mortality | Aliskiren | ||
| Total, all-cause mortality | Enalapril | ||
| Total, other adverse events | Combination of Aliskiren and Enalapril | 1,698 | 2,347 |
| Total, other adverse events | Aliskiren | 1,605 | 2,348 |
| Total, other adverse events | Enalapril | 1,623 | 2,345 |
| Total, serious adverse events | Combination of Aliskiren and Enalapril | 1,466 | 2,347 |
| Total, serious adverse events | Aliskiren | 1,504 | 2,348 |
| Total, serious adverse events | Enalapril | 1,501 | 2,345 |
Source ClinicalTrials.gov
Papers11
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00853658
GET https://conductscience.org/api/trials/v1/NCT00853658/events?page=2