A randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipinetreatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy - ND

OVARTIS FARMA0 个研究点目标入组 1,244 人开始时间: 2006年1月24日最近更新: 2012年4月3日

适应症

试验速览

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•-Male or female outpatients, age between 18- 75 years of age, inclusive, at Visit 1 -Stage/grade 1 or 2 hypertension, MSSBP maggiore/uguale a 140 mmHg, and/or MSDBP maggiore/uguale a 90 mmHg, at visit 1 and 2 in untreated patients; untreated is defined as treatment naive or patients not treated in the past 12 weeks or patients who are currently treated on monotherapy and uncontrolled and have a blood pressure 8804; 160/100 mmHg at Visit 1 and Visit 2. Treatment is defined as having taken medication until 8804; 2 days prior to Visit 1. Treatment is defined as having taken medication for a minimum of 4 weeks and until 8804; 2 days prior to Visit 1. Patients who neither meet the definition of treated or untreated will not be eligible for study entry. -Written informed consent to participate in the 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

•-Current treatment with a CCB -MSSBP / 180 mmHg o MSDBP / 110 mmHg at any time between visit1 and visit 2 -history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures -Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyper-aldosteronism, renal artery stenosis, or pheochromocytoma, etc -Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 -Transient ischemic cerebral attack during the last 6 months, prior to Visit 1 -History of/or symptoms consistent with congestive heart failure -Clinically significant valvular heart disease -Second or third degree heart block without a pacemaker -Concomitant angina pectoris -Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia -Diabetes mellitus -Serum potassium 3.5 or 5.5 mmol/L without medication at Visit 1 -Serum creatinine 1.5 ULN at Visit 1 or a history of dialysis or nephrotic syndrome

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