Resumen

This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

Elegibilidad

Edad mínima: 55 YearsSexo: ALL

Criterios de inclusión

Male or female outpatients ≥ 55 years of age
Patients with essential hypertension measured using a validated automated oscillometric device at Visit 1
Non-treated patients must have a MSSBP ≥ 140 mmHg and ≤ 160 mmHg
Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP ≤ 160 mmHg
To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP ≥ 130 mmHg and ≤ 160 mmHg
No peripheral edema at Visit 2 (randomization)
Written informed consent to participate in this study prior to any study procedures

Criterios de exclusión

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
Patients taking more than 1 antihypertensive medication at Visit 1
Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization
msSBP \> 180 mmHg or msDBP \> 110 mmHg at any time between Visit 1 and Visit 2
Evidence of a secondary form of hypertension, including but not limited to any of the following: Coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma
History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
History of heart failure Grade II - IV according to the NYHA classification
Second or third degree heart block with or without a pacemaker
Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
Concomitant unstable angina pectoris
Clinically significant valvular heart disease
Patients with Type 1 diabetes mellitus
Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator's judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1
Evidence of hepatic disease as determined by one of the following: AST or ALT values \> 2x UNL at study entry, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
Evidence of renal impairment as determined by one of the following: serum creatinine \> 1.5 x UNL at visit 1, history of dialysis, or history of nephrotic syndrome
Serum potassium values \> 5.5 mmol/L at study entry
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
Any surgical or medical condition which, at the discretion of the investigator or Novartis medical monitor, places the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study period
Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
Any severe, life-threatening disease within the past five years
History of drug or alcohol abuse within the last 2 years
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent
Persons directly involved in the execution of this protocol

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Valsartan 160 mg capsules

Amlodipine 5 mg capsules

placebo

Ubicaciones

sites in Argentina

Patrocinadores