Trial · NCT01599104
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
NCT01599104, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension. Trials, record NCT01599104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01599104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
- NCT number
- NCT01599104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,161 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Essential Hypertension
- Interventions
- LCZ696, Olmesartan, Placebo
- First posted
- 2012-05-15
- Last updated
- 2015-10-16
- Results first posted
- 2015-08-06
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 Mean Sitting Systolic Blood Pressure (msSBP) | Baseline, 8 weeks | Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | Baseline, 8 weeks | Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, 8 weeks | Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. |
| Secondary | Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 | 8 weeks | A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg. |
| Secondary | Percentage of Participants Achieving a Successful msSBP Response | 8 weeks | Successful msSBP response was defined as \< 140 mmHg or ≥ 20 mmHg reduction from baseline. |
| Secondary | Percentage of Participants Achieving a Successful msDBP Response | 8 weeks | Successfull msDBP response was defined as \<90 mmHg or ≥10 mmHg reduction from baseline. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 | Baseline, 8 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in maSBP and maDBP for Daytime/Nighttime | Baseline, 8 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in Office Pulse Pressure | Baseline, 8 weeks | Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure | Baseline, 8 weeks | Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants. |
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 Mean Sitting Systolic Blood Pressure (msSBP) | Baseline, 8 weeks | Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 | 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful msSBP Response | 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful msDBP Response | 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in maSBP and maDBP for Daytime/Nighttime | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Office Pulse Pressure | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure | Baseline, 8 weeks | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group48
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 Mean Sitting Systolic Blood Pressure (msSBP) | LCZ696 200 mg | -18.21 | Standard Error 0.702 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | LCZ696 400 mg | -20.18 | Standard Error 0.704 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Olmesartan 20 mg | -13.20 | Standard Error 0.700 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | LCZ696 200 mg | -13.44 | Standard Error 0.445 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | LCZ696 400 mg | -14.99 | Standard Error 0.445 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | Olmesartan 20 mg | -8.78 | Standard Error 0.462 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 200 mg | -7.76 | Standard Error 0.404 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 400 mg | -8.79 | Standard Error 0.406 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Olmesartan 20 mg | -5.91 | Standard Error 0.404 | mmHg | |
| Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 | LCZ696 200 mg | 43.9 | Percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 200 mg | 387 | |
| Overall Study | STARTED | LCZ696 400 mg | 385 | |
| Overall Study | STARTED | Olmesartan 20 mg | 389 | |
| Overall Study | COMPLETED | LCZ696 200 mg | 371 | |
| Overall Study | COMPLETED | LCZ696 400 mg | 371 | |
| Overall Study | COMPLETED | Olmesartan 20 mg | 363 | |
| Overall Study | NOT COMPLETED | LCZ696 200 mg | 16 | |
| Overall Study | NOT COMPLETED | LCZ696 400 mg | 14 | |
| Overall Study | NOT COMPLETED | Olmesartan 20 mg | 26 |
Source ClinicalTrials.gov
Adverse events33
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 | NASOPHARYNGITIS | Infections and infestations | LCZ696 200 mg | 48 | 387 | |
| other | NASOPHARYNGITIS | Infections and infestations | LCZ696 400 mg | 47 | 385 | |
| other | NASOPHARYNGITIS | Infections and infestations | Olmesartan 20 mg | 46 | 389 | |
| serious | ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | LCZ696 200 mg | 0 | 387 | |
| serious | ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | LCZ696 400 mg | 1 | 385 | |
| serious | ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | Olmesartan 20 mg | 0 | 389 | |
| serious | SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | LCZ696 200 mg | 0 | 387 | |
| serious | SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | LCZ696 400 mg | 0 | 385 | |
| serious | SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | Olmesartan 20 mg | 1 | 389 | |
| serious | CATARACT | Eye disorders | LCZ696 200 mg | 0 | 387 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 200 mg | ||
| Total, all-cause mortality | LCZ696 400 mg | ||
| Total, all-cause mortality | Olmesartan 20 mg | ||
| Total, other adverse events | LCZ696 200 mg | 48 | 387 |
| Total, other adverse events | LCZ696 400 mg | 47 | 385 |
| Total, other adverse events | Olmesartan 20 mg | 46 | 389 |
| Total, serious adverse events | LCZ696 200 mg | 1 | 387 |
| Total, serious adverse events | LCZ696 400 mg | 1 | 385 |
| Total, serious adverse events | Olmesartan 20 mg | 7 | 389 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37026551 | DERIVED |
Source PubMed
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.
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