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

Phase 3CompletedNCT01593787

Novartis Pharmaceuticals32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension With Renal Dysfunction

Interventions

LCZ696DRUG

100 mg, 200 mg, 400 mg tablets.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (13)

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: baseline, 8 weeks

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8

Time frame: 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

Time frame: 8 weeks

Percentage of Participants Achieving SBP Control at Week 8

SBP control was defined as msSBP \<130 mmHg.

Time frame: 8 weeks

Percentage of Participants Achieving DBP Control at Week 8

DBP control was defined as msDBP \<80 mmHg.

Time frame: 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

Time frame: 8 weeks

Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8

Data from ClinicalTrials.gov

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