hypertension = high blood pressure increased arterial pressure
Conditions
Interventions
All patients are on placebo for 2 weeks.
Subsequently, patients are treated with one of the following treatments during
8 weeks, depending on their treatment group: LCZ696 100mg, LCZ696 200mg, LCZ69
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For complete list, please refer to the protocol pg 17;- Male or female patients from 18 up to and including 75 years - Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs) -Untreated patients must have an office MSDBP higher than or equal to 95 mmHg at the randomization visit (V3) and the 2 preceding visits (V1 and V2) -Pretreated patients must have an office MSDBP higher than or equal to 90 mmHg after washout (V2), and a MSDBP higher than or equal to 95 mmHg at baseline (V3)
Exclusion criteria
Exclusion criteria: For complete list, please refer to protocol pg 17/18;-Severe hypertension (MSSBP equal to or higher than 180 mmHg and/or MSDBP equal to or higher than 110 mmHG) - Known or suspected contraindications, including history of allergy to ARBs, NEPis or to drugs with a similar chemical structure - History of angiodema, drug-related or otherwise, as reported by the patient -Type 1 or Type 2 diabetes mellitus (according to the ADA criteria) - 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. - History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA, carotid artery stenosis, aortic aneurysm or peripheral arterial disease - Women of child-bearing potential, unless they are post-menopausal or use predefined acceptable methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MSDBP (mean sitting diastolic blood pressure) at trough from baseline (visit 3) to the endpoint visit. For definitions of MSDP and endpoint visit, please refer to protocol pg 50, paragraph 10.4.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in MSDBP and MSSBP at trough from baseline for each dose of studied drug - Successful responder rate in MSDBP ( | — |
Countries
Netherlands
Outcome results
None listed