Severe Hypertension
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Satisfy office msSBP>=180 mmHg or office msDBP>=110 mmHg at baseline.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events Summarize the overall report of adverse event, serious adverse events including death, discontinuation due to adverse events, and notable laboratory abnormalities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) at week 8 Sitting BP measurements will be performed at screening through the end of study at every visit. Four separate sitting BP will be obtained with a full two-minute interval between measurements. Percentage of patients with successful blood pressure (BP) control rate in msSBP/msDBP at endpoint Successful control rate is defined as msSBP/msDBP= 20 mmHg from baseline Percentage of patients achieving a successful response rate in msDBP Successful response rate in msDBP is defined as = 10 mmHg from baseline | — |
Outcome results
None listed