This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
160 mg film coated tablets taken orally once daily in the morning.
5 mg or 10 mg tablets taken orally once daily in the morning.
12.5 mg or 25 mg tablets taken orally once daily in the morning.
25 centers in Germany
Ludwigshafen, Germany
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
Time frame: Baseline to week 52
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
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Time frame: Baseline to week 52
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
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
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100 mg tablets taken orally once daily in the morning.
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Time frame: Baseline to week 52
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
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline to week 52
Percentage of Participants Achieving Target Blood Pressure at Week 52
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.
Time frame: Week 52
Percentage of Participants Who Experienced Adverse Events (AEs)
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.
Time frame: Baseline to week 52