An 8-week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension
CompletadoFase 3ClinicalTrials.gov
ID: NCT00739973Tipo: INTERVENTIONALInicio: 1 de sept de 2008Fin estimado: 1 de may de 2009
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.
Elegibilidad
Edad mínima: 18 YearsSexo: ALL
Criterios de inclusión
msDBP ≥ 90 mmHg and \< 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
msDBP ≥ 95 mmHg and \< 110 mmHg at Visit 3 (Day 1 / randomization).
All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).
Criterios de exclusión
Severe hypertension
Pregnant or nursing (lactating) women
Women of child-bearing potential
Previous or current diagnosis of heart failure (NYHA Class II-IV).
Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
Uncontrolled Type 1 or Type 2 diabetes mellitus
Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
History of malignancy within 5 years
History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Intervenciones
drug
Placebo
drug
Aliskiren 150 mg tablet
drug
Aliskiren 300 mg tablet
drug
Amlodipine 5 mg capsule
drug
Amlodipine 10 mg capsule
drug
Aliskiren/amlodipine 150/5 mg tablet
drug
Aliskiren/amlodipine 150/10 mg tablet
drug
Aliskiren/amlodipine 300/5 mg tablet
drug
Aliskiren/amlodipine 300/10 mg tablet
Ubicaciones
Investigative Site
Buenos Aires, Argentina
Patrocinadores
PrincipalNovartis Pharmaceuticals
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