A Double-blind Study to Evaluate the Efficacy and Safety of LCZ696 in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 5 mg Monotherapy Treatment

A Randomized, 8-week, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 5 mg Monotherapy Treatment

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221905

Enrollment

236

Registered

2012-09-04

Start date

2012-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension

Interventions

investigational material(s) Generic name etc : LCZ696 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients must have a diagnosis of hypertension: -Untreated patients must have an msSBP >= 150 mmHg and = 145 mmHg and = 145 mmHg and < 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201). -Patients must successfully complete ABPM and pass technical requirements at Visit 201.

Exclusion criteria

Exclusion criteria: -Malignant or severe hypertension (grade 3 of WHO classification;msDBP >= 110 mmHg and/or msSBP >= 180 mmHg). -History of angioedema, drug-related or otherwise. -History or evidence of a secondary form of hypertension. -Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke. -History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1 .

Design outcomes

Primary

Measure	Time frame
Change in mean 24-hour ABPM systolic blood pressure (maSBP) [ Time Frame: 8 weeks ] Measure the change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups. A greater reduction from baseline in the LCZ696 group will indicate whether there is a positive treatment effect.	—

Secondary

Measure	Time frame
Change in mean 24-hour ABPM diastolic blood pressure (maDBP) [ Time Frame: 8 weeks ] Measure the change in mean 24 hour ambulatory diastolic blood pressure (maDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in mean sitting systolic blood pressure (msSBP) [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting systolic blood pressure (msSBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in mean sitting diastolic blood pressure (msDBP) [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting diastolic blood pressure (msDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in sitting pulse pressure [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting pulse pressure from baseline to end of the study. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure. Percentage of patients achieving systolic and diastolic blood pressure control (= 20 mmHg from baseline) [ Time Frame: 8 weeks ] The percentage of patients that achieve successful treatment response in the mean sitting systolic blood pressure (msSBP) of = 20 mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as a having a successful response. Percentage of patients achieving successful response in msDBP (= 10 mmHg from baseline) [ Time Frame: 8 weeks of treament ] The percentage of patients that achieve successful treatment response in the mean sitting diastolic blood pressure (msDBP) of = 10mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as having a successful response. Number of patients with adverse event [ Time Frame: 8	—

Measure

Time frame

Change in mean 24-hour ABPM diastolic blood pressure (maDBP) [ Time Frame: 8 weeks ] Measure the change in mean 24 hour ambulatory diastolic blood pressure (maDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in mean sitting systolic blood pressure (msSBP) [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting systolic blood pressure (msSBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in mean sitting diastolic blood pressure (msDBP) [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting diastolic blood pressure (msDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect. Change in sitting pulse pressure [ Time Frame: 8 weeks ] Measure the change in the patient's mean sitting pulse pressure from baseline to end of the study. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure. Percentage of patients achieving systolic and diastolic blood pressure control (= 20 mmHg from baseline) [ Time Frame: 8 weeks ] The percentage of patients that achieve successful treatment response in the mean sitting systolic blood pressure (msSBP) of = 20 mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as a having a successful response. Percentage of patients achieving successful response in msDBP (= 10 mmHg from baseline) [ Time Frame: 8 weeks of treament ] The percentage of patients that achieve successful treatment response in the mean sitting diastolic blood pressure (msDBP) of = 10mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as having a successful response. Number of patients with adverse event [ Time Frame: 8

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026