A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00778921Tipo: INTERVENTIONALInicio: 1 de oct de 2008Fin estimado: 1 de jun de 2009

Traducción no disponible, mostrando original

Resumen

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 5 (randomization)

Criterios de exclusión

Severe hypertension
Pregnant or nursing (lactating) women
Pre-menopausal women not taking accepted form of birth control
Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
History of cardiovascular conditions
Uncontrolled Type 1 or Type 2 diabetes mellitus
Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Intervenciones

drug

Amlodipine 10 mg

drug

Aliskiren 150

Aliskiren/Amlodipine 150/10 mg

drug

Amlodipine 300

Aliskiren/Amlodipine 300/10 mg

Ubicaciones

Investigative Site

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis

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