patients with mild-to-moderate hypertension and left ventricular hypertrophy MedDRA version: 8.1 Level: LLT Classification code 10049773 Term: Left ventricular hypertrophy
Conditions
Interventions
Trade Name: Diovan 160 mg Filmtabletten
Product Name: Diovan 160mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =90 and =95 and = 12.0mm and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a noninferior or superior efficacy of the combination of valsartan 160mg and amlodipine 5mg compared with the combination of losartan 100mg and HCTZ 12.5mg by testing the hypothesis that the regression of LVH, as measured by the change in LVMI [g/m2] via MRI from baseline to end of study is at least irrelevantly smaller or even larger under valsartan/amlodipine compared to losartan/HCTZ in patients with mild-to moderate hypertension and LVH.;Secondary Objective: • To evaluate the efficacy of the combination of valsartan/amlodipine compared with the combination of losartan/HCTZ on the change in LVH parameters (such as left ventricular wall thickness, left ventricular ejection fraction, left ventricular end-diastolic volume, left ventricular endsystolic volume) assessed by MRI. • To evaluate the effect of both combinations on the change in LVH parameters and left ventricular diastolic function as assessed by centrally read ECHO. • To evaluate the impact of both combinations on the change in NT-proBNP and High-Sensitivity C-Reactive Protein. • To compare the effects of both combination therapies on the proportion of patients, who achieve without rescue medication the target blood pressure of MSSBP < 140 mm Hg and MSDBP < 90 mm Hg. • To evaluate the overall safety and tolerability of the combination of valsartan/amlodipine compared with the combination of losartan/HCTZ in patients with essential hypertension and LVH. ;Primary end point(s): The primary efficacy variable is the change from baseline of the left ventricular mass index (LVMI). | — |
Countries
Germany
Outcome results
None listed