Trial · NCT01256411
A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
NCT01256411, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension. Trials, record NCT01256411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
- NCT number
- NCT01256411
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 341 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Essential Hypertension
- Interventions
- LCZ696, Amlodipine, Hydrochlorothiazide (HCTZ)
- First posted
- 2010-12-08
- Last updated
- 2015-10-21
- Results first posted
- 2015-10-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | Baseline to 12 months | Participants were monitored throughout the study for adverse events, serious adverse events and deaths. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) | Baseline, 12 months | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) | Baseline, 12 months | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. |
| Secondary | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) | Baseline to 12 months | Blood pressure (BP) control is defined as BP \<140/90 mmHg. |
| Secondary | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) | Baseline to 12 months | Blood pressure (BP) control is defined as BP \<140/90 mmHg. |
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 | Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | Baseline to 12 months | Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) | Baseline, 12 months | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) | Baseline, 12 months | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | mmHg | MEAN |
| SECONDARY | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) | Baseline to 12 months | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) | Baseline to 12 months | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 200 mg | Adverse events (serious and non-serious) | 147 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 400 mg | Adverse events (serious and non-serious) | 78 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ606 400 mg/Amlodipine | Adverse events (serious and non-serious) | 53 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 400 mg/Amlodipine/HCTZ | Adverse events (serious and non-serious) | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 100 mg | Adverse events (serious and non-serious) | 6 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 200 mg | Seroius adverse events | 10 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 400 mg | Seroius adverse events | 2 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ606 400 mg/Amlodipine | Seroius adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 400 mg/Amlodipine/HCTZ | Seroius adverse events | 0 | Participants | |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | LCZ696 100 mg | Seroius adverse events | 1 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Extension by Maximum Treatment | STARTED | LCZ696 200 mg | 139 | |
| Extension by Maximum Treatment | STARTED | LCZ696 400 mg | 89 | |
| Extension by Maximum Treatment | STARTED | LCZ606 400 mg/Amlodipine | 109 | |
| Extension by Maximum Treatment | STARTED | LCZ696 400 mg/Amlodipine/HCTZ | 4 | |
| Extension by Maximum Treatment | STARTED | LCZ696 Monotherapy | 0 | |
| Extension by Maximum Treatment | STARTED | LCZ696 Combination Therapy | 0 | |
| Extension by Maximum Treatment | Down Titrated to 100 mg | LCZ696 200 mg | 12 | |
| Extension by Maximum Treatment | Down Titrated to 100 mg | LCZ696 400 mg | 0 | |
| Extension by Maximum Treatment | Down Titrated to 100 mg | LCZ606 400 mg/Amlodipine | 0 | |
| Extension by Maximum Treatment | Down Titrated to 100 mg | LCZ696 400 mg/Amlodipine/HCTZ | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events175
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 | Dysphagia | Gastrointestinal disorders | LCZ696 100 mg | 1 | 12 | |
| other | Dysphagia | Gastrointestinal disorders | LCZ696 200 mg | 0 | 340 | |
| other | Dysphagia | Gastrointestinal disorders | LCZ696 400 mg | 0 | 201 | |
| other | Dysphagia | Gastrointestinal disorders | LCZ696 400 mg/Aml | 0 | 112 | |
| other | Dysphagia | Gastrointestinal disorders | LCZ696 400 mg/Aml/HCTZ | 0 | 4 | |
| other | Gastric ulcer | Gastrointestinal disorders | LCZ696 100 mg | 1 | 12 | |
| other | Gastric ulcer | Gastrointestinal disorders | LCZ696 200 mg | 0 | 340 | |
| other | Gastric ulcer | Gastrointestinal disorders | LCZ696 400 mg | 1 | 201 | |
| other | Gastric ulcer | Gastrointestinal disorders | LCZ696 400 mg/Aml | 1 | 112 | |
| other | Gastric ulcer | Gastrointestinal disorders | LCZ696 400 mg/Aml/HCTZ | 0 | 4 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 100 mg | ||
| Total, all-cause mortality | LCZ696 200 mg | ||
| Total, all-cause mortality | LCZ696 400 mg | ||
| Total, all-cause mortality | LCZ696 400 mg/Aml | ||
| Total, all-cause mortality | LCZ696 400 mg/Aml/HCTZ | ||
| Total, other adverse events | LCZ696 100 mg | 6 | 12 |
| Total, other adverse events | LCZ696 200 mg | 77 | 340 |
| Total, other adverse events | LCZ696 400 mg | 39 | 201 |
| Total, other adverse events | LCZ696 400 mg/Aml | 32 | 112 |
| Total, other adverse events | LCZ696 400 mg/Aml/HCTZ | 0 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LCZ696 Monotherapy vs LCZ696 Combination Therapy: Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) |
Source 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/NCT01256411
GET https://conductscience.org/api/trials/v1/NCT01256411/results?page=2