Essential Hypertension
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy. -Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP >= 150 mmHg and = 140 mmHg = 150 mmHg and < 180 mmHg at both Visit 1 and Visit 201. -Patients must have an absolute difference of =< 15 mmHg in msSBP between Visit 201 and the immediately preceding visit.
Exclusion criteria
Exclusion criteria: -Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg). -History of angioedema, drug-related or otherwise, as reported by the patient. -History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. -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 |
|---|---|
| Change from baseline in mean sitting systolic blood pressure (msSBP) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean 24-hour ambulatory SBP(maSBP) at week8 Ambulatory blood pressure monitoring (ABPM) over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 8 Sitting BP measurement 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 measurement. Percentage of patients achieving a successful response overall blood pressure control at week 8 endpoint A successful response in overall BP control rate defined as msSBP = 20 mmHg reduction from baseline. Percentage of patients achieving a successful in msDBP response at week 8 Successful msDBP response defined as = 10 mmHg reduction from baseline. Change from baseline in mean 24-hour ambulatory DBP(maDBP) at week 8 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Change from baseline in maSBP and maDBP for daytime/nighttime at week 8 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Change from baseline in office pulse pressure at week 8 Sitting BP measurement 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 measurement. Change from baseline in mean 24-hour ambulatory pulse pressure at week 8 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Number of patients with adverse events, serious adverse events and death Summarized report on adverse events such as number of patients with total adverse events, serious adverse events and death will be reported. | — |
Outcome results
None listed