Trial · NCT04164732
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
NCT04164732, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2024-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy. Trials, record NCT04164732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04164732
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
- NCT number
- NCT04164732
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cardiomyopathy, Hypertrophic
- Interventions
- LCZ696, Placebo
- First posted
- 2019-11-15
- Last updated
- 2025-05-16
- Other registries' IDs
- eudract:2019-003098-24
- Results first posted
- 2024-08-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET) | Baseline to 50 weeks | The primary analysis assessed the effect of LCZ696 on the change from baseline in peak Volume of Oxygen (VO2) (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 came from the screening/baseline CPET. An increase in peak VO2 (mL/kg/min)/positive change is considered beneficial for the patient. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET) | Baseline to 50 weeks | Patients in the per protocol analysis set with and available value for the outcome measure at baseline and Week 50 .~Per protocol analysis set consists of all randomized patients who had no major protocol deviations with relevant impact on PD/efficacy data and who are at least 80% compliant with the overall study drug administration. | mL/kg/min | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET) | LCZ696 BID | 1.00 | 90% Confidence Interval -0.22 to 2.23 | mL/kg/min | |
| Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET) | Placebo BID | 0.39 | 90% Confidence Interval -0.80 to 1.58 | mL/kg/min |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment run-in Period | STARTED | Run-in (All Participants) | 46 | |
| Treatment run-in Period | STARTED | LCZ696 BID | 0 | |
| Treatment run-in Period | STARTED | Placebo BID | 0 | |
| Treatment run-in Period | COMPLETED | Run-in (All Participants) | 40 | |
| Treatment run-in Period | COMPLETED | LCZ696 BID | 0 | |
| Treatment run-in Period | COMPLETED | Placebo BID | 0 | |
| Treatment run-in Period | NOT COMPLETED | Run-in (All Participants) | 6 | |
| Treatment run-in Period | NOT COMPLETED | LCZ696 BID | 0 | |
| Treatment run-in Period | NOT COMPLETED | Placebo BID | 0 | |
| Randomized Treatment Period | STARTED | Run-in (All Participants) | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events312
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 | Run-In Period Placebo | 0 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Run-In LCZ696 50 mg | 0 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period Placebo | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period LCZ696 50 mg | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period LCZ696 100 mg | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period LCZ696 200 mg | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Double-blind Period LCZ696 | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 1 | 46 | |
| other | Palpitations | Cardiac disorders | Run-In Period Placebo | 0 | 46 | |
| other | Palpitations | Cardiac disorders | Run-In LCZ696 50 mg | 0 | 43 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-In Period Placebo | 0 | 46 |
| Total, all-cause mortality | Run-In LCZ696 50 mg | 0 | 43 |
| Total, all-cause mortality | Double-blind Period Placebo | 0 | 20 |
| Total, all-cause mortality | Double-blind Period LCZ696 50 mg | 0 | 1 |
| Total, all-cause mortality | Double-blind Period LCZ696 100 mg | 0 | 20 |
| Total, all-cause mortality | Double-blind Period LCZ696 200 mg | 0 | 17 |
| Total, all-cause mortality | Double-blind Period LCZ696 | 0 | 20 |
| Total, all-cause mortality | Total | 0 | 46 |
| Total, other adverse events | Run-In Period Placebo | 4 | 46 |
| Total, other adverse events | Run-In LCZ696 50 mg | 4 | 43 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04164732
GET https://conductscience.org/api/trials/v1/NCT04164732/flow?page=2