Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

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Detailed Description

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Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Conditions

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Severe Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LCZ696 200 mg

All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

LCZ696 200 mg tablet once daily

LCZ696 400 mg

All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily

LCZ696 400 mg plus other hypertension (HTN) medications

All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications

Interventions

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LCZ696

LCZ696 200 mg tablet once daily

Intervention Type DRUG

LCZ696

2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily

Intervention Type DRUG

LCZ696

2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria

* Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
* History of angioedema, drug-related or otherwise, as reported by the patient
* Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
* Patients have significant cardiovascular co-morbidities
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No