A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Official Title
-----------------
An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: LCZ696
* Drug: Amlodipine
* Drug: Hydrochlorothiazide (HCTZ)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study. Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219. Exclusion Criteria: Patients who did not complete CLCZ696A2219. Presence of significant protocol violation in CLCZ696A2219. Patients who are deemed to be unable to comply with the protocol by the investigator. Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCZ696<br> | Drug: LCZ696<br>* Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.<br>Drug: Amlodipine<br>* Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.<br>Drug: Hydrochlorothiazide (HCTZ)<br>* Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | Participants were monitored throughout the study for adverse events, serious adverse events and deaths. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. | Baseline, 12 months | 
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. | Baseline, 12 months | 
| Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Baseline to 12 months | 
| Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor, angiotensin receptor neprilysin inhibitor (ARNi)