A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1018

Inclusion Criteria

1.Male or female outpatients = 55 years of age
2.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
3.To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP =?130 mmHg and = 160 mmHg
4.No peripheral edema at Visit 2 (randomization)
5.Written informed consent to participate in this study prior to any study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
2.Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
3.Patients taking more than 1 antihypertensive medication at Visit 1
4.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
5.MSSBP > 180mmHg or MSDBP ? 110 mmHg at any time between Visit 1 and Visit 2
6.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
7.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
8.History of heart failure Grade II - IV according to the NYHA classification
9.Second or third degree heart block with or without a pacemaker
10.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
11.Concomitant unstable angina pectoris
12.Clinically significant valvular heart disease
13.Patients with Type 1 diabetes mellitus
14.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.
15.Evidence of hepatic disease as determined by one of the following: AST or ALT values > 2 x UNL at Visit 1, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
16.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
17.Serum potassium values > 5.5 mmol/L at Visit 1
18.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug
19.Any surgical or medical condition which, at the discretion of the investigator or Novartis medical monitor, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
20.Volume depletion based on the investigator’s clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
21.Any severe, life-threatening disease within the past five years
22.History of drug or alcohol abuse within the last 2 years
23.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
24.Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent
25.Persons directly involved in the exe