Trial · NCT01876368
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
NCT01876368, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan. Trials, record NCT01876368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876368
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
- NCT number
- NCT01876368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 376 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- LCZ696, Olmesartan, Placebo of LCZ696, Placebo of Olmesartan
- First posted
- 2013-06-12
- Last updated
- 2015-12-07
- Other registries' IDs
- eudract:2013-001783-36
- Results first posted
- 2015-12-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | baseline, 8 weeks | Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | baseline, 8 weeks | Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, 8 weeks | Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, 8 weeks | Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean |
| Secondary | Change From Baseline in Office Pulse Pressure | baseline, 8 weeks | Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP. |
| Secondary | Number of Patients Achieving Successful Overall Blood Pressure Control | 8 weeks | Successful overall blood pressure control is defined as both msSBP/msDBP \<140/90 mmHg |
| Secondary | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control | 8 weeks | Successful mean sitting systolic blood pressure control is defined as msSBP \<140 mmHg |
| Secondary | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control | 8 weeks | Successful mean sitting diastolic blood pressure control is defined as msDBP \<90 mmHg |
| Secondary | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response | baseline, 8 weeks | Successful mean sitting systolic blood pressure response is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline. |
| Secondary | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response | baseline, 8 weeks | Successful mean sitting diastolic blood pressure response is defined as msDBP \<90 mmHg or a reduction ≥10 mmHg from baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | baseline, 8 weeks | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | baseline, 8 weeks | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Office Pulse Pressure | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Achieving Successful Overall Blood Pressure Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group26
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 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | LCZ696 200 mg | -4.26 | Standard Error 0.60 | mmHg | |
| Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | Olmesartan 20 mg | -1.04 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | LCZ696 200 mg | -2.27 | Standard Error 0.39 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | Olmesartan 20 mg | -0.35 | Standard Error 0.39 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | LCZ696 200 mg | -14.21 | Standard Error 1.28 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Olmesartan 20 mg | -10.03 | Standard Error 1.29 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 200 mg | -7.52 | Standard Error 0.70 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Olmesartan 20 mg | -4.47 | Standard Error 0.71 | mmHg | |
| Change From Baseline in Office Pulse Pressure | LCZ696 200 mg | -6.67 | Standard Error 0.94 | mmHg | |
| Change From Baseline in Office Pulse Pressure | Olmesartan 20 mg | -5.54 | Standard Error 0.94 | mmHg |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 200 mg | 188 | |
| Overall Study | STARTED | Olmesartan 20 mg | 188 | |
| Overall Study | Full Analysis Set (FAS) | LCZ696 200 mg | 188 | |
| Overall Study | Full Analysis Set (FAS) | Olmesartan 20 mg | 187 | |
| Overall Study | Safety Set (SAF) | LCZ696 200 mg | 188 | |
| Overall Study | Safety Set (SAF) | Olmesartan 20 mg | 187 | |
| Overall Study | COMPLETED | LCZ696 200 mg | 179 | |
| Overall Study | COMPLETED | Olmesartan 20 mg | 175 | |
| Overall Study | NOT COMPLETED | LCZ696 200 mg | 9 | |
| Overall Study | NOT COMPLETED | Olmesartan 20 mg | 13 |
Source ClinicalTrials.gov
Adverse events8
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 | DIZZINESS | Nervous system disorders | LCZ696 200 mg | 2 | 188 | |
| other | DIZZINESS | Nervous system disorders | Olmesartan 20 mg | 4 | 187 | |
| other | HEADACHE | Nervous system disorders | LCZ696 200 mg | 5 | 188 | |
| other | HEADACHE | Nervous system disorders | Olmesartan 20 mg | 6 | 187 | |
| serious | BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | LCZ696 200 mg | 0 | 188 | |
| serious | BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olmesartan 20 mg | 1 | 187 | |
| serious | CEREBROVASCULAR ACCIDENT | Nervous system disorders | LCZ696 200 mg | 0 | 188 | |
| serious | CEREBROVASCULAR ACCIDENT | Nervous system disorders | Olmesartan 20 mg | 1 | 187 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 200 mg | ||
| Total, all-cause mortality | Olmesartan 20 mg | ||
| Total, other adverse events | LCZ696 200 mg | 7 | 188 |
| Total, other adverse events | Olmesartan 20 mg | 10 | 187 |
| Total, serious adverse events | LCZ696 200 mg | 0 | 188 |
| Total, serious adverse events | Olmesartan 20 mg | 2 | 187 |
Source ClinicalTrials.gov
Papers0
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LCZ696 200 mg vs Olmesartan 20 mg: Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control | Trial comparisons |
| LCZ696 200 mg vs Olmesartan 20 mg: Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response | Trial comparisons |
| LCZ696 200 mg vs Olmesartan 20 mg: Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control | Trial comparisons |
| LCZ696 200 mg vs Olmesartan 20 mg: Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response | Trial comparisons |
| LCZ696 200 mg vs Olmesartan 20 mg: Number of Patients Achieving Successful Overall Blood Pressure Control | Trial comparisons |
| LCZ696 200 mg vs Olmesartan 20 mg: 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/NCT01876368
GET https://conductscience.org/api/trials/v1/NCT01876368/results?page=2