Trial · NCT02661217
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
NCT02661217, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event. Trials, record NCT02661217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02661217
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
- NCT number
- NCT02661217
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,002 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- LCZ696
- First posted
- 2016-01-22
- Last updated
- 2021-04-26
- Other registries' IDs
- eudract:2015-003266-87
- Results first posted
- 2021-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization | 10 weeks after Randomization | Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10 |
| Secondary | Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid | 10 weeks after Randomization | Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10 |
| Secondary | Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 | 10 weeks after Randomization | Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment |
| Secondary | Percentage of Patients Permanently Discontinued From Treatment | 10 weeks after Randomization AND 26 weeks after randomization | Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization | 10 weeks after Randomization | Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid | 10 weeks after Randomization | Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 | 10 weeks after Randomization | Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Permanently Discontinued From Treatment | 10 weeks after Randomization AND 26 weeks after randomization | Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | All Collected Deaths | From randomization until 26 weeks after randomization | Safety Population (SAF) and randomized patients who died prior to first dose of study drug. The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization | LCZ696 Pre-discharge Treatment Initiation | 224 | Participants | ||
| Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization | LCZ696 Post-discharge Treatment Initiation | 248 | Participants | ||
| Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid | LCZ696 Pre-discharge Treatment Initiation | 306 | Participants | ||
| Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid | LCZ696 Post-discharge Treatment Initiation | 335 | Participants | ||
| Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 | LCZ696 Pre-discharge Treatment Initiation | 424 | Participants | ||
| Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 | LCZ696 Post-discharge Treatment Initiation | 438 | Participants | ||
| Percentage of Patients Permanently Discontinued From Treatment | LCZ696 Pre-discharge Treatment Initiation | up to week 10 due to AEs | 36 | Participants | |
| Percentage of Patients Permanently Discontinued From Treatment | LCZ696 Post-discharge Treatment Initiation | up to week 10 due to AEs | 24 | Participants | |
| Percentage of Patients Permanently Discontinued From Treatment | LCZ696 Pre-discharge Treatment Initiation | up to week 26 due to any reasons | 83 | Participants | |
| Percentage of Patients Permanently Discontinued From Treatment | LCZ696 Post-discharge Treatment Initiation | up to week 26 due to any reasons | 78 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 Pre-discharge Treatment Initiation | 500 | |
| Overall Study | STARTED | LCZ696 Post-discharge Treatment Initiation | 502 | |
| Overall Study | Started 10 Weeks Treatment Epoch | LCZ696 Pre-discharge Treatment Initiation | 497 | |
| Overall Study | Started 10 Weeks Treatment Epoch | LCZ696 Post-discharge Treatment Initiation | 501 | |
| Overall Study | Completed 10 Weeks Treatment Epoch | LCZ696 Pre-discharge Treatment Initiation | 460 | |
| Overall Study | Completed 10 Weeks Treatment Epoch | LCZ696 Post-discharge Treatment Initiation | 455 | |
| Overall Study | COMPLETED | LCZ696 Pre-discharge Treatment Initiation | 425 | |
| Overall Study | COMPLETED | LCZ696 Post-discharge Treatment Initiation | 419 | |
| Overall Study | NOT COMPLETED | LCZ696 Pre-discharge Treatment Initiation | 75 | |
| Overall Study | NOT COMPLETED | LCZ696 Post-discharge Treatment Initiation | 83 |
Source ClinicalTrials.gov
Adverse events588
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 | Diarrhoea | Gastrointestinal disorders | Pre-discharge | 17 | 493 | |
| other | Diarrhoea | Gastrointestinal disorders | Post-discharge | 29 | 489 | |
| other | Diarrhoea | Gastrointestinal disorders | All Patients | 46 | 982 | |
| other | Oedema peripheral | General disorders | Pre-discharge | 20 | 493 | |
| other | Oedema peripheral | General disorders | Post-discharge | 26 | 489 | |
| other | Oedema peripheral | General disorders | All Patients | 46 | 982 | |
| other | Urinary tract infection | Infections and infestations | Pre-discharge | 29 | 493 | |
| other | Urinary tract infection | Infections and infestations | Post-discharge | 19 | 489 | |
| other | Urinary tract infection | Infections and infestations | All Patients | 48 | 982 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Pre-discharge | 67 | 493 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-discharge | 23 | 493 |
| Total, all-cause mortality | Post-discharge | 13 | 489 |
| Total, all-cause mortality | All Patients | 36 | 982 |
| Total, other adverse events | Pre-discharge | 200 | 493 |
| Total, other adverse events | Post-discharge | 201 | 489 |
| Total, other adverse events | All Patients | 401 | 982 |
| Total, serious adverse events | Pre-discharge | 159 | 493 |
| Total, serious adverse events | Post-discharge | 134 | 489 |
| Total, serious adverse events | All Patients | 293 | 982 |
Source ClinicalTrials.gov
Papers5
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 Pre-discharge Treatment Initiation vs LCZ696 Post-discharge Treatment Initiation: Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid | Trial comparisons |
| LCZ696 Pre-discharge Treatment Initiation vs LCZ696 Post-discharge Treatment Initiation: Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization | Trial comparisons |
| LCZ696 Pre-discharge Treatment Initiation vs LCZ696 Post-discharge Treatment Initiation: Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 | 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/NCT02661217
GET https://conductscience.org/api/trials/v1/NCT02661217/events?page=2