None listed
Conditions
Interventions
The sponsor will provide the following study medications in bottles. The packaging will be
identical in appearance.
• LCZ696 200 mg tablets
• LCZ696 400 mg, given as two LCZ696 200 mg tablets
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients aged ≥ 18 years (at the time of signing informed consent). 2. Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy 3. Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP ≥150 mmHg and <180 mmHg at the randomization visit and msSBP ≥140 mmHg <180 mmHg at the preceding visit. 4. Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥150 mmHg and <180 mmHg at both the randomization visit and the preceding visit. 5. Patients must have an absolute difference of ≤15 mmHg in msSBP between the randomization visit and the preceding visit. 6. Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.
Exclusion criteria
Exclusion criteria: 1. Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg) 2. History of angioedema, drug-related or otherwise 3. 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 druginduced hypertension 4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke 5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1 6. Pregnant or lactating women 7. Women of child-bearing potential not using highly effective methods of contraception
Countries
Argentina, Brazil, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Peru, Philippines, Russian Federation, Slovakia, South Africa, Spain, Thailand, United States, Vietnam
Contacts
Public ContactOscar Barrenechea
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed