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.
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
sites in Argentina, Agentina, Argentina
sites in Chile, Chile, Chile
sites in Ecuador, Ecuador, Ecuador
sites in Finland, Finland, Finland
sites in France, France, France
sites in Germany, Germany, Germany
sites in Italy, Italy, Italy
sites in Norway, Norway, Norway
sites in Spain, Spain, Spain
sites in Sweden, Sweden, Sweden
sites in Switzerland, Switzerland, Switzerland
sites in Turkey, Turkey, Turkey