Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

Study Overview
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Brief Summary
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This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Official Title
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A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

Conditions
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Hypertension With Renal Dysfunction

Intervention / Treatment
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* Drug: LCZ696


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit. Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline. Exclusion Criteria: Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg. History of angioedema, drug-related or otherwise, as reported by the patient. Any other following renal disorder: Patients show eGFR < 15mL/min/1.73m^2 Patients on dialysis Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCZ696 100 mg<br>All participants were started on LCZ696 100 mg once daily on day 1. | Drug: LCZ696<br>* 100 mg, 200 mg, 400 mg tablets.<br>|
| Experimental: LCZ696 200 mg<br>All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. | Drug: LCZ696<br>* 100 mg, 200 mg, 400 mg tablets.<br>|
| Experimental: LCZ696 400 mg<br>All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. | Drug: LCZ696<br>* 100 mg, 200 mg, 400 mg tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) | Percentage of patients with total adverse events, serious adverse events and death were reported. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 | 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. | baseline, 8 weeks | 
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 |  | baseline, 8 weeks | 
| Percentage of Participants Achieving a Successful BP Control at Week 8 | A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg | 8 weeks | 
| Percentage of Participants Achieving SBP Control at Week 8 | SBP control was defined as msSBP <130 mmHg. | 8 weeks | 
| Percentage of Participants Achieving DBP Control at Week 8 | DBP control was defined as msDBP <80 mmHg. | 8 weeks | 
| Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 | Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline | 8 weeks | 
| Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 | Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Renal dysfunction, LCZ696