An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal

CompletadoFase 3ClinicalTrials.gov

ID: NCT00706134Tipo: INTERVENTIONALInicio: 1 de may de 2008Fin estimado: 1 de abr de 2009

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Elegibilidad

Edad mínima: 65 YearsSexo: ALL

Criterios de inclusión

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and \< 180 mmHg (msDBP \<110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Criterios de exclusión

Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Severe hypertension \[Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg\].
History or evidence of a secondary form of hypertension.
Current angina pectoris requiring pharmacological therapy other than nitrates.

Intervenciones

drug

Placebo

Placebo tablet taken once daily in the morning with a light meal.

drug

Aliskiren 75 mg

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

drug

Aliskiren 150 mg

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

drug

Aliskiren 300 mg

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Ubicaciones

Investigative Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis

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