Trial · NCT01785472
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
NCT01785472, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension. Trials, record NCT01785472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785472
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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 Asian Patients With Essential Hypertension
- NCT number
- NCT01785472
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,438 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Essential Hypertension
- Interventions
- LCZ696, Olmesartan, Placebo of LCZ696, Placebo of Olmesartan
- First posted
- 2013-02-07
- Last updated
- 2016-12-29
- Results first posted
- 2015-09-04
Source ClinicalTrials.gov
Registered outcomes13
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) Between LCZ696 200 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement |
| Secondary | Change From Baseline in Office Pulse Pressure (msPP) | baseline, 8 weeks | Four separate sitting BP measurements should be obtained with a full two minute interval between measurements. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Blood Pressure | baseline, 8 weeks | In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study. |
| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers. | baseline, 8 weeks | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement |
| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers. | baseline, 8 weeks | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement |
| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers. | baseline, 8 weeks | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement |
| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers. | baseline, 8 weeks | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement |
| Secondary | Number of Patients Achieving Successful Blood Pressure Control | 8 weeks | Successful blood pressure control is defined as msSBP \<140 mmHg and msDBP \<90 mmHg. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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) Between LCZ696 200 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | baseline, 8 weeks | Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments | mmHg | MEAN |
| SECONDARY | Change From Baseline in Office Pulse Pressure (msPP) | baseline, 8 weeks | Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Blood Pressure | baseline, 8 weeks | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers. | baseline, 8 weeks | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | mmHg | MEAN |
| SECONDARY | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers. | baseline, 8 weeks | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | mmHg | MEAN |
| SECONDARY | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers. | baseline, 8 weeks | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | mmHg | MEAN |
| SECONDARY | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers. | baseline, 8 weeks | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | mmHg | MEAN |
| SECONDARY | Number of Patients Achieving Successful Blood Pressure Control | 8 weeks | Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments. | Number of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group322
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) Between LCZ696 200 mg Versus Olmesartan 20 mg | LCZ696 200 mg | -20.48 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg | Olmesartan 20 mg | -18.15 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg | LCZ696 400 mg | -21.67 | Standard Error 0.62 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg | Olmesartan 20 mg | -18.15 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | LCZ696 200 mg | -8.10 | Standard Error 0.37 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | LCZ696 400 mg | -8.80 | Standard Error 0.38 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | Olmesartan 20 mg | -6.86 | Standard Error 0.37 | mmHg | |
| Change From Baseline in Office Pulse Pressure (msPP) | LCZ696 200 mg | -12.35 | Standard Error 0.42 | mmHg | |
| Change From Baseline in Office Pulse Pressure (msPP) | LCZ696 400 mg | -12.93 | Standard Error 0.43 | mmHg | |
| Change From Baseline in Office Pulse Pressure (msPP) | Olmesartan 20 mg | -11.25 | Standard Error 0.42 | mmHg |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 200 mg | 479 | |
| Overall Study | STARTED | LCZ696 400 mg | 473 | |
| Overall Study | STARTED | Olmesartan 20 mg | 486 | |
| Overall Study | Full Analysis Set (FAS) | LCZ696 200 mg | 479 | |
| Overall Study | Full Analysis Set (FAS) | LCZ696 400 mg | 472 | |
| Overall Study | Full Analysis Set (FAS) | Olmesartan 20 mg | 484 | |
| Overall Study | Safety Set (SAF) | LCZ696 200 mg | 478 | |
| Overall Study | Safety Set (SAF) | LCZ696 400 mg | 472 | |
| Overall Study | Safety Set (SAF) | Olmesartan 20 mg | 484 | |
| Overall Study | COMPLETED | LCZ696 200 mg | 455 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events66
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 | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | LCZ696 200 mg | 15 | 478 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | LCZ696 400 mg | 5 | 472 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Olmesartan 20 mg | 8 | 484 | |
| other | BLOOD GLUCOSE INCREASED | Investigations | LCZ696 200 mg | 5 | 478 | |
| other | BLOOD GLUCOSE INCREASED | Investigations | LCZ696 400 mg | 10 | 472 | |
| other | BLOOD GLUCOSE INCREASED | Investigations | Olmesartan 20 mg | 13 | 484 | |
| other | HYPERLIPIDAEMIA | Metabolism and nutrition disorders | LCZ696 200 mg | 16 | 478 | |
| other | HYPERLIPIDAEMIA | Metabolism and nutrition disorders | LCZ696 400 mg | 22 | 472 | |
| other | HYPERLIPIDAEMIA | Metabolism and nutrition disorders | Olmesartan 20 mg | 21 | 484 | |
| other | HYPERURICAEMIA | Metabolism and nutrition disorders | LCZ696 200 mg | 14 | 478 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 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 | 66 | 478 |
| Total, other adverse events | LCZ696 400 mg | 63 | 472 |
| Total, other adverse events | Olmesartan 20 mg | 66 | 484 |
| Total, serious adverse events | LCZ696 200 mg | 5 | 478 |
| Total, serious adverse events | LCZ696 400 mg | 3 | 472 |
| Total, serious adverse events | Olmesartan 20 mg | 6 | 484 |
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 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/NCT01785472
GET https://conductscience.org/api/trials/v1/NCT01785472/results?page=2