A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

CompletadoFase 2ClinicalTrials.gov

ID: NCT00549770Tipo: INTERVENTIONALInicio: 1 de sept de 2007Fin estimado: 1 de jul de 2008

Traducción no disponible, mostrando original

Resumen

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male or females 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; therapy with a fixed dose combination of two active substances represents 2 drugs)
Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP\> 95 mmHg at baseline (Visit 3);

Criterios de exclusión

Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
History of angioedema, 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, 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 (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Intervenciones

drug

LCZ696

drug

Valsartan

drug

AHU377

drug

Placebo

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Corrientes Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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