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

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension

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

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.

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.