Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

• Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
  Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
• Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: No ]
• Percentage of Participants Achieving Target Blood Pressure at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.
• Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: Yes ]
  An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.

• To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to a change in parameters such as left ventricular wall thickness, left ventricular ejection fraction, left ventricular end
• To compare the combination of val 160mg and aml 5mg with the combination of losartan 100mg and HCTZ 12.5mg with regard to the impact of both combinations on the change in NT-proBNP and High-Sensitivity C-Reactive Protein.
• To evaluate the overall safety and tolerability of the combination of val 160mg and aml5mg compared with the combination of losartan 100mg and HCTZ 12.5mg in patients with essential hypertension and left ventricular hypertrophy

This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

• Drug: Valsartan
  160 mg film coated tablets taken orally once daily in the morning.
• Drug: Amlodipine
  5 mg or 10 mg tablets taken orally once daily in the morning.
• Drug: Hydrochlorothiazide
  12.5 mg or 25 mg tablets taken orally once daily in the morning.
• Drug: Losartan
  100 mg tablets taken orally once daily in the morning.

• Experimental: Amlodipine + Valsartan
  Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
  Interventions:

  • Drug: Valsartan
  • Drug: Amlodipine
• Active Comparator: Losartan + Hydrochlorothiazide
  Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
  Interventions:

  • Drug: Hydrochlorothiazide
  • Drug: Losartan

Inclusion Criteria:

• Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
• Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
• Patients with Left Ventricular Hypertrophy

Exclusion Criteria:

• Severe hypertension
• Symptomatic heart failure
• History of stroke, heart attack, coronary bypass surgery etc.
• Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.

Other protocol-defined inclusion/exclusion criteria may apply