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

Novartis

Status and phase: Completed; Phase 3

Conditions: Severe Hypertension

Treatments: Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646671

CLCZ696A1305

Details and patient eligibility

About

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

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

LCZ696 200 mg

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: LCZ696

Drug: LCZ696

LCZ696 400 mg

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: LCZ696

Drug: LCZ696

LCZ696 400 mg plus other hypertension (HTN) medications

Experimental group

Description:

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.

Treatment:

Drug: LCZ696

Drug: LCZ696

Drug: LCZ696