A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

CompletadoFase 2ClinicalTrials.gov

ID: NCT01281306Tipo: INTERVENTIONALInicio: 1 de ene de 2011Fin estimado: 1 de dic de 2011

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Criterios de exclusión

Severe hypertension
History of angioedema, drug-related or otherwise, as reported by the patient.
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
History or evidence of a secondary form of hypertension.

Intervenciones

drug

LCZ696

LCZ696 was supplied as tablets in blister cards in 100 mg strengths.

drug

Valsartan

Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.

drug

AHU377

AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.

drug

Placebo

Placebo was supplied as tablets in blister cards.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Lanús, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires F.D., Argentina

Novartis Investigative Site

Corrientes, Corrientes Province, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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