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

• Conditions: Essential hypertension; MedDRA version: 6.1Level: PTClassification code 10015488

• Registration Number: EUCTR2005-000684-26-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-24
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1244

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified