An open-label, randomized, parallel group study comparing the efficacy and safety of Amlodipine in combination with Valsartan compared to Losartan in combination with Hydrochlorothiazide given for 52 weeks on the regression of left ventricular hypertrophy in patients with mild-to-moderate hypertension - Examine LVH

Conditions: patients with mild-to-moderate hypertension and left ventricular hypertrophy
MedDRA version: 8.1Level: LLTClassification code 10049773Term: Left ventricular hypertrophy

Registration Number: EUCTR2006-001977-17-DE

Lead Sponsor: ovartis Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
2.Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy (limited to one active compound) and with a MSDBP of >=90 and <= 110mmHg at visit 1
or
with a combination therapy (limited to up to 3 active compounds; patients treated with 3 active compounds can only be included when all the three compounds were not already given in the highest approved dose level prior to study entry) and with a MSDBP of >=90 and <= 105mmHg at visit 1. Patients who are currently not treated with antihypersensitive drugs may be included with a MSDBP of >=95 and <=110mmHg at visit 1.
3.Patients with LVH (LVWT >= 12.0mm and <= 16.0mm; determined by the highest value either by the posterior wall thickness [PWTd] or by the interventricular septal wall thickness [IVSTd]) confirmed by ECHO at Visit 2 prior to randomization.
4.Patients who are eligible, able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

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.Known or suspected contraindications as listed in the national prescribing information, to any of the study drugs (valsartan, losartan, amlodipine and HCTZ; Appendices 3-6) or to drugs with similar chemical structures or to drugs belonging to the same therapeutic class.
2.Severe refractory hypertension defined as confirmed reading of MSSBP > 180 mm Hg or MSDBP of > 110 mm Hg at any visit.
3.History of secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, etc..
4.Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e., idiopathic or valvular). Hemodynamically significant mitral stenosis or lesions of the left ventricular outflow tract including aortic stenosis or hypertrophic obstructive cardiomyopathy.
5.History of symptomatic heart failure (NYHA classes II-IV) or a LVEF < 50% confirmed by ECHO prior to randomization.
6.A history of stroke, transient ischemic cerebral attack, hypertensive encephalopathy, coronary artery bypass surgery, percutaneous transluminal angioplasty or myocardial infarction anytime prior to visit 1.
7.Concurrent life threatening arrhythmia or symptomatic arrhythmia.
8.Known history of angioneurotic oedema.
9.Evidence of hepatic disease or cholestasis as determined by any one of the following: AST (SGOT) or ALT (SGPT) values exceeding 3 x ULN at Visit 1.
10.Insulin dependent Diabetes mellitus or uncontrolled treated Type 2 Diabetes mellitus with poor glucose control defined as HbA1c > 7.0 % at Visit 1.
11.Documented history of clinically significant peripheral edema.
12.Second or third degree heart block, sick sinus syndrome or sinuatrial block.
13.Patients with non-sinus rhythm or frequent extrasystoles (>6/min).
14.Known or suspected contraindication for MRI
•use of pacemakers, ICD, defibrillators or any device which interferes with an MRI or presence of cranial aneurysm clips or ocular metallic shards.
•Patients who cannot lie supine for at least 30 minutes, who cannot hold their breath for 15 seconds, who are suffering from significant claustrophobia (not responsive to light intravenous anxiolytics or whose body structure (e.g., weight, height, body circumference, etc.) exceeds the restrictions of the local MRI site instrument.
15.Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy < 1 year).
16.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
17.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
18.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
19.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural