A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

CompletadoFase 3ClinicalTrials.gov

ID: NCT01876368Tipo: INTERVENTIONALInicio: 1 de sept de 2013Fin estimado: 1 de ago de 2014

Traducción no disponible, mostrando original

Resumen

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

patients with mild to moderate hypertension, untreated or currently taking antihypertensive therapy
treated patients (using antihypertensive drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after washout epoch and after 4 weeks run-in epoch
untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and \< 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after 4 weeks run-in epoch
patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Criterios de exclusión

Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
History of angioedema, drug-related or otherwise
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 (PKD), drug-induced hypertension
Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Intervenciones

drug

LCZ696

drug

Olmesartan

drug

Placebo of LCZ696

drug

Placebo of Olmesartan

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires F.D., Argentina

Novartis Investigative Site

Corrientes, Corrientes Province, Argentina

Novartis Investigative Site

Posadas, Misiones Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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