Essential Hypertension
Conditions
Interventions
Product Code: LCZ696
Pharmaceutical Form: Tablet
Current Sponsor code: LCZ696
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the
Sponsors
NOVARTIS PHARMA SERVICES AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients from 18 up to including 75 years 2. Patients with mild-to-moderate uncomplicated essential hypertension, treatment naïve or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs). 3. Treatment naïve patients must have an office mean sitting diastolic blood pressure (MSDBP) = 95 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For full list, please refer to protocol. 1. Severe hypertension (MSSBP =180 mmHg and/or MSDBP =110 mmHg) 2. Known or suspected contraindications, including history of allergy to ARBs, NEPi’s or to drugs with a similar chemical structure. 3. History of angioedema, drug-related or otherwise as reported by the patient 4. History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing’s disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD), etc. 5. Type 1 or Type 2 diabetes mellitus 6. History of angina perctoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneaous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis or peripheral arterial disease 7. Previous or current diagnosis of congestive heart failure NYHA Class II to IV 8. Second or third degree heart block without a pacemaker 9. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia 10. Clinically significant valvular heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the full dose range of LCZ696 (100, 200, and 400 mg) in patients with essential hypertension by testing the hypotheses of superiority in mean sitting diastolic blood pressure (MSDBP) lowering from baseline to week 8 (or endpoint) when compared to valsartan (80, 160, and 320 mg). Endpoint is defined as the last post randomization observation if patient is earlier discontinued prior to Visit 6.;Secondary Objective: For the full list, please refer to protocol. • To evaluate the efficacy of the full dose range of LCZ696 (100, 200, and 400 mg) in patients with essential hypertension by testing the hypotheses of superiority in mean sitting diastolic blood pressure (MSDBP) and systolic blood pressure (MSSBP) lowering from baseline to week 8 (or endpoint) when compared to placebo • To demonstrate that 400 mg LCZ696 has superior efficacy compared to 320 mg valsartan in reducing MSDBP from baseline to 8 weeks (or endpoint) of treatment in patients with essential hypertension • To demonstrate that 200 mg LCZ696 has superior efficacy compared to 160 mg valsartan in reducing MSDBP from baseline to 8 weeks (or endpoint) of treatment in patients with essential hypertension ;Primary end point(s): The primary variable is the change from baseline (Visit 3) in MSDBP at trough to endpoint. MSDBP is defined as the average of available readings of the sitting diastolic blood pressures from one visit. For the endpoint, the last available post-baseline MSDBP during the 8-week core period will be considered as the endpoint measurement. | — |
Countries
Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Spain, Sweden
Outcome results
None listed